The Recall Desk

Archive

November 2015 recalls

745 recalls were announced in November 2015.

What the numbers show

Critical
22
Severe
397
High
235
Moderate
76
Low
15

Of the 745 recalls this month scored against our rubric, 3% are Critical, 53% are Severe.

301–400 of 745

  • HighNHTSA·15V778000·2015-11-20

    Isuzu Recalls NPR and NQR Trucks Due to Fire Extinguisher Defect

    Isuzu is recalling 2012-2016 NPR, NQR, and NRR trucks because the installed fire extinguishers may fail to discharge. Owners should contact Isuzu or Kidde for a free replacement.

    Product
    ISUZU — ISUZU NPR XD, NPR HD, NQR, NPR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V779000·2015-11-20

    Ford E-Series Vans Recalled for Wheelchair Lift Bearing Defect

    New England Wheels is recalling 2006-2014 Ford E-250 and E-350 vans with specific Ricon wheelchair lifts. Defective pivot holes may allow bearings to shift, causing the lift platform to fall and injure the operator.

    Product
    FORD — FORD E-250, E-350
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V775000·2015-11-20

    Nissan Recalls 2015 Rogue Vehicles for Shift Selector Defect

    Nissan is recalling 2015 Rogue vehicles because the shift selector knob may allow shifting out of Park without depressing the brake pedal, increasing the risk of a crash.

    Product
    NISSAN — NISSAN ROGUE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V774000·2015-11-19

    Utility Trailer Recalls 2015 VS2RA Models Due to Brake Caliper Bolt Issue

    Utility Trailer is recalling 2015 VS2RA Refrigerated Van trailers because improperly tightened caliper bolts may detach, reducing braking performance and increasing crash risk.

    Product
    UTILITY — UTILITY VS2RA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V772000·2015-11-19

    IC CE School Buses Recalled for Wheelchair Lift Bearing Defect

    Kingmor is recalling 271 IC CE school buses equipped with specific Ricon wheelchair lifts. Defective pivot holes may allow bearings to shift, causing the lift platform to fall and injure operators.

    Product
    IC BUS — IC BUS, IC CE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·142-2015·2015-11-19

    Nation Pizza Recalls Frozen Pepperoni Pizzas Due to Undeclared Soy

    Nation Pizza is recalling approximately 59,028 pounds of frozen Mama Cozzis Pizza Kitchen products because they contain undeclared soy, a known allergen.

    Product
    Nestle USA. INC. — Nation Pizza Recalls Mama Cozzi's Pizza Kitchen Products Due To Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    4 states
  • HighNHTSA·15V770000·2015-11-19

    Micro Bird Transit Bus Wheelchair Lift Recall for Bearing Defect

    Micro Bird is recalling 2006-2014 transit buses with Ricon wheelchair lifts where oversized pivot holes may allow bearings to shift, risking platform failure.

    Product
    MICRO BIRD — MICRO BIRD CT-SERIES, MB II TRANSIT BUS, G5 TRANSIT BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15E092000·2015-11-19

    Gillig Recalls Ricon Wheelchair Lifts Due to Bearing Failure Risk

    Gillig is recalling Ricon Model S5510 wheelchair lifts because oversized pivot holes may allow bearings to shift, potentially causing the platform to fall and injure the operator.

    Product
    EQUIPMENT ADAPTIVE/MOBILITY recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V773000·2015-11-19

    Coach and Equipment Recalls Transit Buses with Defective Wheelchair Lifts

    Coach and Equipment is recalling 2006-2014 transit buses equipped with certain Ricon wheelchair lifts. The lifts may have pivot holes that allow bearings to move, risking platform failure.

    Product
    COACH AND EQUIPMENT — COACH AND EQUIPMENT ALLEY CAT, METRO LITE, PEGASUS, PHOENIX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V771000·2015-11-19

    Forest River Recalls 2012-2016 RVs With Atwood Water Heater Defect

    Forest River is recalling specific 2012-2016 recreational vehicles because a water heater valve may cause overheating, potentially leading to steam release and scalding injuries.

    Product
    COACHMEN — COACHMEN, FOREST RIVER, CONTINENTAL CARGO BROOKSTONE, LEGACY, SHOCKWAVE, WORK AND PLAY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·16041·2015-11-19

    Bostitch Electric Pencil Sharpeners Recalled by Amax Due to Shock Hazard

    Amax is recalling Bostitch electric pencil sharpeners because internal components can energize the unit, posing a shock hazard. One consumer reported receiving a shock.

    Product
    Bostitch electric pencil sharpeners
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0183-2016·2015-11-18

    Burger King Apple Slices Recalled for Potential Listeria Contamination

    Appeeling Fruit is recalling Burger King apple slices due to potential Listeria monocytogenes contamination.

    Product
    Burger King Crown, Apple Slices, Net Wt. 2 oz., Best If Used By: 9/14/2015; packed 20-2 oz. pouches to a case. Distributed by: Burger King Corporation, Miami, FL 33126
    Category
    Food
    Distribution
    5 states
  • CriticalFDA (Food)·F-0182-2016·2015-11-18

    Appeeling Fruit Recalls Fresh Sliced Apples Due to Listeria Risk

    Appeeling Fruit Inc. is voluntarily recalling fresh sliced apples with specific dates due to potential Listeria monocytogenes contamination.

    Product
    Appeeling Fruit Inc.,Dauberville, PA 19533; Fresh Slices, Net Wt. 20 # Bulk, Best If Used By: 9/18/2015 Appeeling Fruit Inc., Dauberville, PA 19533 (bulk-packed), 4 CT/3 lb. Sweet Apple Slices Best If Used By: 9/18/2015. Packed 4 - 3lb boxes/case.
    Category
    Food
    Distribution
    5 states
  • CriticalFDA (Drugs)·D-0229-2016·2015-11-18

    Miracle Rock 48 capsules recalled for containing undeclared thiosildenafil

    The One Minute Miracle Inc. is recalling Miracle Rock 48 capsules because they contain undeclared thiosildenafil, an unapproved drug analogue.

    Product
    MIRACLE ROCK 48 capsules, packaged in 2 x 2-count blisters, 4-count capsules per carton, Manufactured Exclusively For: The One Minute Miracle Inc., UPC 0911312397354.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0230-2016·2015-11-18

    Miracle Diet 30 Recalled for Undeclared Phenolphthalein

    The One Minute Miracle Inc. is recalling Miracle Diet 30 capsules because they contain undeclared phenolphthalein, an unapproved drug ingredient.

    Product
    MIRACLE DIET 30 capsules, 30-count bottle, Manufactured Exclusively For: The One Minute Miracle Inc., UPC 7 538073516768.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0185-2016·2015-11-18

    Appeeling Fruit Recalls Wegman's Apple Wedges and Edges for Listeria Risk

    Appeeling Fruit Inc. is voluntarily recalling Wegman's apple wedges and edges due to potential Listeria monocytogenes contamination.

    Product
    Wegman's, Organic Apple Wedges, Net Wt. 12 oz., 6 pouches, UPC: 0 77890 28213, Best If Used By: 9/21/2015; packed 6 - 12 oz. packages/case; Wegman's, Apple Edges, Net Wt. 16 oz., 8 pouches, UPC: 0 77890 25018, Best If Used By: 9/21/2015; packed 6 - 16 oz. packages/case.
    Category
    Food
    Distribution
    5 states
  • CriticalFDA (Food)·F-0190-2016·2015-11-18

    Andrew & Williamson Recalls Limited Edition Cucumbers Due to Salmonella Risk

    Andrew & Williamson Fresh Produce is recalling Limited Edition cucumbers because they may be contaminated with Salmonella.

    Product
    1 1/9 Bushel Limited Edition Cucumber Carton, Sizes: Plains (60-84 count), Extra Large (48 count), Large (60 count), Super Select (72 count), Super Select Special (84 count). These cucumbers are shipped in a black, green, yellow, and craft colored carton which reads Limited Ed
    Category
    Food
    Distribution
    22 states
  • CriticalFDA (Food)·F-0189-2016·2015-11-18

    Andrew & Williamson Recalls Limited Edition Cucumbers Due to Salmonella Risk

    Andrew & Williamson Fresh Produce is recalling Limited Edition cucumbers because they may be contaminated with Salmonella. The recall affects 57,704 units distributed across 22 states.

    Product
    5/4 Limited Edition Cucumber Carton, Sizes 24SP, 36/36SP, 48. These cucumbers are shipped in a black, green, yellow, and craft colored carton which reads Limited Edition Pole Grown Cucumbers. This variety is often referred to as a Slicer or American cucumber. It has a dark g
    Category
    Food
    Distribution
    22 states
  • SevereFDA (Drugs)·D-0189-2016·2015-11-18

    The Compounder Recalls Biest TD 67/33 Transdermal Cream Due to Penicillin Contamination

    The Compounder is recalling Biest TD 67/33 transdermal cream because the active ingredient was contaminated with penicillin. The recall covers 10 syringes per lot distributed nationwide.

    Product
    BIEST TD 67/33 (Estradiol (E2) TRIT (YELLOW)/Estriol USP Micronized (E3)) W/V (weight /volume) 1.5 MG/ML Transdermal cream, dispensed in 3 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0181-2016·2015-11-18

    Appeeling Fruit Recalls Fresh Sliced Apple Wedges Due to Listeria Risk

    Appeeling Fruit Inc. is voluntarily recalling fresh sliced apple wedges due to potential contamination with Listeria monocytogenes.

    Product
    Appeeling Fruit, Sweet Fresh, Apple Wedges, Net Wt. 16 oz. 8 2 oz. bags, UPC: 6 58324 08400, Best If Used By: 9/21/2015, Packed 6 - 8 unit packages/case; Appeeling Fruit, Sweet Fresh, Apple Wedges, Net Wt. 12 oz., , Best If Used By: 9/21/2015, Packed 6 packages/case;
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Food)·F-0184-2016·2015-11-18

    Appeeling Fruit Recalls Fresh Sliced Apples Due to Listeria Risk

    Appeeling Fruit, Inc. is voluntarily recalling fresh sliced apples due to potential contamination with Listeria monocytogenes.

    Product
    Snack Fresh, Red Apple Slices, Net Wt. 2 oz., UPC: 0 74641 00982, Best If Used By: 9/21/2015; Distributed by Country Fresh, LLC. , Houston, TX 77090; packed 100-2 oz. pouches to a case
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Drugs)·D-0227-2016·2015-11-18

    The Compounder Recalls TRIEST 80/10/10 Capsules Due to Penicillin Contamination

    The Compounder is recalling TRIEST 80/10/10 capsules because the active ingredient was contaminated with penicillin. Patients should stop using the medication and consult a healthcare provider.

    Product
    TRIEST 80/10/10 (E1/E2 Trit - Estrone (E1)/Estradiol (E2) / Estriol USP (E3)) (23) 5MG capsules, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0217-2016·2015-11-18

    The Compounder Recalls Transdermal Cream Due to Penicillin Cross-Contamination

    The Compounder is recalling specific lots of a compounded transdermal cream because an active ingredient was contaminated with penicillin.

    Product
    ESTRIOL (E3) : ESTRADIOL (E2) (Estradiol (E2) Trit (Yellow)) : PROGEST (Progesterone USP) : TESTO (Testosterone USP) W/V (weight/volume) 2 :0.1 : 35 : 0.5 MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0208-2016·2015-11-18

    The Compounder Recalls BIEST TD 80/20 Cream Due to Penicillin Contamination

    The Compounder is recalling BIEST TD 80/20 transdermal cream because the active ingredient was contaminated with penicillin by a supplier.

    Product
    BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) VAN CR (vanishing cream) W/V (weight/volume) (4812) 2.5MG/ML Transdermal cream, dispensed in a) 1mL and b)3 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 605
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0173-2016·2015-11-18

    B&B Pharmacy Recalls PAPA/PGE1/PHENTO Injection Due to Sterility Concerns

    Pacific Healthcare, Inc dba B&B Pharmacy is recalling PAPA/PGE1/PHENTO Injection vials because an FDA inspection identified GMP violations that may impact sterility.

    Product
    PAPA/PGE1/PHENTO (22.5mg/8.33mcg/0.833mg/ml) Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0211-2016·2015-11-18

    The Compounder Recalls Biest TD 89/11 Transdermal Cream Due to Penicillin Contamination

    The Compounder is recalling Biest TD 89/11 transdermal cream because the active ingredient was contaminated with penicillin. Patients should stop using the product and consult their healthcare provider.

    Product
    BIEST TD 89/11 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) W/V (weight/volume) VERSABASE 2.25MG/ML Transdermal cream, dispensed in 3 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0166-2016·2015-11-18

    Nandrolone Injection Recalled Due to Sterility Assurance Concerns

    Pacific Healthcare is recalling Nandrolone 200 mg/ml Injection vials because an FDA inspection found GMP violations that may impact sterility.

    Product
    Nandrolone 200 mg/ml Injection, 10 mL and 20 mL vials, Rx, B & B Health Mart Pharmacy, Bellflower, CA
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0194-2016·2015-11-18

    The Compounder Recalls BIEST TD 80/20 Cream Due to Penicillin Contamination

    The Compounder is recalling BIEST TD 80/20 transdermal cream because the active ingredient was contaminated with penicillin by a supplier.

    Product
    BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3)) W/V (weight/volume) 5 MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0190-2016·2015-11-18

    The Compounder Recalls BIEST TD 80/20 Transdermal Cream Due to Penicillin Contamination

    The Compounder is recalling BIEST TD 80/20 transdermal cream because the active ingredient was contaminated with penicillin by a supplier.

    Product
    BIEST TD 80/20 (Estradiol USP Micronized (E2)/Estriol USP Micronized (E3)) W/V (weight /volume) 8 MG/ML transdermal cream, dispensed in 3 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0195-2016·2015-11-18

    The Compounder Recalls Biest TD 80/20 Transdermal Cream Due to Penicillin Contamination

    The Compounder is recalling Biest TD 80/20 transdermal cream because the active ingredient was contaminated with penicillin. Patients should stop using the product and contact their healthcare provider.

    Product
    BIEST TD 80/20 (Estriol USP Micronized (E3)/Estradiol (E2) Trit (Yellow)) W/V(weight/volume) [2977] 6.25MG/ML Transdermal cream, dispensed in 1 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0224-2016·2015-11-18

    The Compounder Recalls Estriol Cream Due to Penicillin Contamination

    The Compounder is recalling specific lots of Estriol transdermal cream because the active ingredient was contaminated with penicillin.

    Product
    ESTRIOL (E3) W/V (weight/volume) VERSABASE [4714] 0.05% (0.5MG/ML) transdermal cream, dispensed in a) 1 mL and b) 3 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0170-2016·2015-11-18

    B&B Pharmacy Recalls PAPA/PHENTO Injection Due to Sterility Concerns

    Pacific Healthcare, Inc dba B&B Pharmacy is recalling PAPA/PHENTO Injection vials because FDA inspections identified GMP violations that may affect sterility.

    Product
    PAPA/PHENTO (30mg/1mg/ml) Injection, 5 mL and 10 mL vials, Rx, B & B Health Mart Pharmacy, Bellflower, CA
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0167-2016·2015-11-18

    Testosterone Cypionate Injection Recalled Due to Sterility Assurance Concerns

    Pacific Healthcare, Inc dba B&B Pharmacy is recalling Testosterone Cypionate 250 mg/mL Injection due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Testosterone Cypionate 250 mg/mL Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0247-2016·2015-11-18

    Maquet Adjustable Positioning Elements Recalled Due to Thromboembolic Events

    Maquet is recalling Adjustable Positioning Elements used in spine surgery after two serious thromboembolic events were reported.

    Product
    Maquet Getinge Group, Adjustable Positioning Elements (1007.28A0) Manufacturer: Maquet GmbH, Germany. Patient positioners. The MAQUET Adjustable Positioning Elements are designed for the placement and positioning of patients in the prone position immediately before, during and
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0248-2016·2015-11-18

    Maquet Universal Frame Recalled Due to Thromboembolic Event Reports

    Maquet is recalling Universal Frames and Adjustable Positioning Elements after two serious thromboembolic events were reported during lumbar spine surgery.

    Product
    Maquet Getinge Group, Universal Frame for Positioning Patients (1007.24XX) Manufacturer: Maquet GmbH, Germany The MAQUET Adjustable Positioning Elements are designed for the placement and positioning of patients in the prone position immediately before, during and after surgical
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Drugs)·D-0226-2016·2015-11-18

    The Compounder Recalls TRIEST 70/20/10 Transdermal Cream Due to Penicillin Contamination

    The Compounder is recalling TRIEST 70/20/10 transdermal cream because the active ingredient was contaminated with penicillin. The recall covers 24 syringes per lot.

    Product
    TRIEST 70/20/10 ( Estriol USP / Estradiol USP (E2) / Estrone (E1) Triturate) [909] 12.5MG/ML transdermal cream, dispensed in 1 mL prefilled amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0204-2016·2015-11-18

    The Compounder Recalls BIEST TD 80/20 Cream Due to Penicillin Contamination

    The Compounder is recalling BIEST TD 80/20 transdermal cream because it was made with an active ingredient contaminated with penicillin.

    Product
    BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG (Progesterone USP Micronized) : TESTO (Testosterone USP) : DHEA (Dehydroepiandrosterone Micronized) W/V (weight/volume) VERSABASE 2.5 : 17.5 : 1.25 :0.25MG/ML Transdermal cream, dispensed in 10 mL p
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0228-2016·2015-11-18

    The Compounder Recalls TRIEST 80/10/10 Capsules Due to Penicillin Contamination

    The Compounder is recalling TRIEST 80/10/10 capsules because the active ingredient was contaminated with penicillin. This recall affects nationwide distribution.

    Product
    TRIEST 80/10/10 (Estrone (E1) Trit / Estradiol (E2) Trit / Estriol USP (E3)) 1.875MG capsules, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0216-2016·2015-11-18

    The Compounder Recalls Estradiol and Progesterone Cream Due to Penicillin Contamination

    The Compounder is recalling Estradiol and Progesterone transdermal cream because the active ingredient was contaminated with penicillin.

    Product
    ESTRIOL (E3) : PROGESTERONE W/V (weight/volume) 4.0 : 100 MG/ML Transdermal cream, dispensed in 3 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0186-2016·2015-11-18

    The Compounder Recalls BIEST CP 80/20 Capsules Due to Penicillin Contamination

    The Compounder is recalling BIEST CP 80/20 capsules because the active ingredient was contaminated with penicillin. The recall is nationwide.

    Product
    BIEST CP 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3)) 2.5 MG capsules, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0202-2016·2015-11-18

    The Compounder Recalls Biest TD 80/20 Cream Due to Penicillin Contamination

    The Compounder is recalling Biest TD 80/20 transdermal cream because an active ingredient was contaminated with penicillin. Patients should stop using the product and contact their healthcare provider.

    Product
    BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG (Progesterone USP Micronized) : DHEA (Dehydroepiandrosterone Micronized) IN VERSABASE W/V (weight/volume) 2.5 : 25 :1.25MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only,
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0165-2016·2015-11-18

    Stanozolol Injection Recalled Due to Sterility Assurance Concerns

    Pacific Healthcare, Inc. is recalling Stanozolol 200 mg/ml Injection vials due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Stanozolol 200 mg/ml Injection, 20 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0212-2016·2015-11-18

    The Compounder Recalls Biest TD 91/9 Transdermal Cream Due to Penicillin Contamination

    The Compounder is recalling specific lots of Biest TD 91/9 transdermal cream because the active ingredient was contaminated with penicillin.

    Product
    BIEST TD 91/9 (Estriol USP Micronized (E3)/Estradiol (E2) Trit (Yellow)) : PROGESTERONE W/V (weight/volume) PLO (Pluronic F127 20% or Polox 20% gel) 3.3 MG/ML : 40 MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0197-2016·2015-11-18

    The Compounder Recalls BIEST TD 80/20 Cream Due to Penicillin Contamination

    The Compounder is recalling BIEST TD 80/20 transdermal cream because an active ingredient was contaminated with penicillin. Patients should stop using the product and contact their healthcare provider.

    Product
    BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG (Progesterone USP Micronized): DHEA (Dehydroepiandrosterone Micronized) : TESTO (Testosterone Trit) W/V (weight/volume) VERSABASE 2.5: 30 : 2.5 : 0.25 MG/MLTransdermal cream, dispensed in 10 mL prefi
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0180-2016·2015-11-18

    PGE 25mcg/ml Injection Recalled Due to Sterility Assurance Concerns

    Pacific Healthcare, Inc dba B&B Pharmacy is recalling PGE 25mcg/ml Injection vials because an FDA inspection identified GMP violations that may impact sterility.

    Product
    PGE 25mcg/ml, Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0182-2016·2015-11-18

    The Compounder Recalls Biest 66/34 Due to Penicillin Cross-Contamination

    The Compounder is recalling Biest 66/34 hormone suspension because an active ingredient was contaminated with penicillin. Patients should stop using the product and consult a healthcare provider.

    Product
    BIEST 66/34: TESTOSTERONE : PROGESTERONE IN OLIVE OIL(Estradiol USP Micronized (ED)/Estriol USP Micronized (E3): Testosterone : Progesterone in Olive Oil) 3mg : 4 mg : 100 mg/mL suspension, Rx only, packaged in a 15 mL glass dropper bottle. The Compounder, 340 Marshall Avenue U
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0168-2016·2015-11-18

    Testosterone Propionate Injection Recalled for Sterility Assurance Concerns

    Pacific Healthcare, Inc dba B&B Pharmacy is recalling Testosterone Propionate Injection due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Testosterone prop. 200 mg/ml Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0196-2016·2015-11-18

    The Compounder Recalls Biest TD 80/20 Transdermal Cream Due to Penicillin Contamination

    The Compounder is recalling Biest TD 80/20 transdermal cream because it was made with an active ingredient contaminated with penicillin.

    Product
    BIEST TD 80/20 (Estradiol (E2) Trit (yellow) / Estriol USP Micronized (E3)): PROG (Progesterone USP Micronized) W/V 2.5MG:100MG/ML Transdermal cream, dispensed in 3 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0188-2016·2015-11-18

    The Compounder Recalls Biest TD 50/50 Transdermal Cream Due to Penicillin Contamination

    The Compounder is recalling Biest TD 50/50 transdermal cream because the active ingredient was contaminated with penicillin. Patients should stop using the product and contact their healthcare provider.

    Product
    BIEST TD 50/50 (Estradiol USP Micronized (E2)/Estriol USP Micronized (E3)) W/V (weight /volume) 4.0 MG/ML transdermal cream packaged in 3mL syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0205-2016·2015-11-18

    The Compounder Recalls Biest TD 80/20 Cream Due to Penicillin Contamination

    The Compounder is recalling Biest TD 80/20 transdermal cream because an active ingredient was contaminated with penicillin.

    Product
    BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG (Progesterone USP Micronized) : TESTO (Testosterone USP) W/V (weight/volume) 5.0 :20 :1 MG/ML Transdermal cream, dispensed in 5 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Ave
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0185-2016·2015-11-18

    The Compounder Recalls BIEST CP 80/20 Capsules Due to Penicillin Contamination

    The Compounder is recalling BIEST CP 80/20 capsules because the active ingredient was contaminated with penicillin. Patients should stop using the product and consult their healthcare provider.

    Product
    BIEST CP 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3)) 1.25 MG capsules, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0201-2016·2015-11-18

    The Compounder Recalls BIEST TD 80/20 Cream Due to Penicillin Contamination

    The Compounder is recalling BIEST TD 80/20 transdermal cream because an active ingredient was contaminated with penicillin. Patients should stop using the product and contact their healthcare provider.

    Product
    BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG (Progesterone USP Micronized) : DHEA (Dehydroepiandrosterone Micronized) : TESTO (Testosterone Trit) W/V (weight/volume) VERSABASE 6.5 : 30: 1.25: 0.25 MG/ML Transdermal cream, dispensed in 10 mL pre
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0192-2016·2015-11-18

    The Compounder Recalls Biest TD 80/20 Transdermal Cream Due to Penicillin Contamination

    The Compounder is recalling Biest TD 80/20 transdermal cream because the active ingredient was contaminated with penicillin. Patients should stop using the product and contact their healthcare provider.

    Product
    BIEST TD 80/20 (Estradiol USP Micronized (E2)/Estriol USP Micronized (E3)) W/V (weight /volume) 12.5 MG/ML 1.25MG/0.1ML Transdermal cream, dispensed in 1 mL prefilled, amber syringes,Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0186-2016·2015-11-18

    Appeeling Fruit Recalls Fresh Sliced Apples Due to Listeria Risk

    Appeeling Fruit is voluntarily recalling fresh sliced apples with specific best-if-used-by dates due to potential Listeria monocytogenes contamination.

    Product
    Appeeling Fruit, Tart Fresh, Apple Edges, Net Wt. 12 oz., UPC: 6 58324 00950, Best if used by: 09/21/2015, packed 6 packages/case.
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Drugs)·D-0169-2016·2015-11-18

    B&B Pharmacy Recalls PAPA+PGE1+PHENTO Injection Due to Sterility Concerns

    B&B Pharmacy is recalling PAPA+PGE1+PHENTO Injection vials because an FDA inspection found GMP violations that may affect sterility.

    Product
    PAPA+PGE1+PHENTO (30mg/20mcg/1mg/ml) Injection, 5 mL and 10 mL vials, Rx, B & B Health Mart Pharmacy, Bellflower, CA
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0203-2016·2015-11-18

    FDA Recalls BIEST TD 80/20 Cream Due to Penicillin Contamination

    The Compounder is recalling BIEST TD 80/20 transdermal cream because an active ingredient was contaminated with penicillin. Patients should stop using the product and consult their healthcare provider.

    Product
    BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG (Progesterone USP Micronized) : DHEA (Dehydroepiandrosterone Micronized) IN VERSABASE W/V (weight/volume) 4 : 67.5 :10MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only,
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0209-2016·2015-11-18

    The Compounder Recalls Biest TD 83/17 Cream Due to Penicillin Contamination

    The Compounder is recalling Biest TD 83/17 transdermal cream because the active ingredient was contaminated with penicillin. The recall is nationwide.

    Product
    BIEST TD 83/17 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) W/V (weight/volume) 1.2 MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0222-2016·2015-11-18

    The Compounder Recalls Estriol Cream Due to Penicillin Cross-Contamination

    The Compounder is recalling specific lots of Estriol transdermal cream because the active ingredient was contaminated with penicillin.

    Product
    ESTRIOL (E3) W/V (weight/volume) PGF 0.1% (1.0MG/ML) Transdermal cream, is dispensed in 3 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0174-2016·2015-11-18

    B&B Pharmacy Recalls PAPA/PGE1/PHENTO Injection Due to Sterility Concerns

    Pacific Healthcare, Inc dba B&B Pharmacy is recalling PAPA/PGE1/PHENTO Injection vials because an FDA inspection found GMP violations that may affect sterility.

    Product
    PAPA/PGE1/PHENTO (30mg/10mg/1mg/ml) Injection, 5 mL and 10 mL vials, Rx, B & B Health Mart Pharmacy, Bellflower, CA
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0225-2016·2015-11-18

    The Compounder Recalls Transdermal Cream Due to Penicillin Cross-Contamination

    The Compounder is recalling specific lots of a compounded transdermal cream because the active ingredient was contaminated with penicillin.

    Product
    ESTRIOL 5 ESTRADIOL (Estradiol (E2) Trit (Yellow)) 0.95 ESTRONE (Estrone E1) Trit (Red)) 0.02 TEST (Testosterone USP) 0.75MG/ML W/V (weight/volume) transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0177-2016·2015-11-18

    B&B Pharmacy Recalls PGE 30mcg/ml Injection Due to Sterility Concerns

    Pacific Healthcare, Inc dba B&B Pharmacy is recalling PGE 30mcg/ml Injection vials because an FDA inspection identified GMP violations that may impact sterility.

    Product
    PGE 30mcg/ml Injection, 10 mL vials, Rx, B & B Health Mart Pharmacy, Bellflower, CA
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0187-2016·2015-11-18

    The Compounder Recalls BIEST TD 50/50 Transdermal Cream Due to Penicillin Contamination

    The Compounder is recalling BIEST TD 50/50 transdermal cream because the active ingredient was contaminated with penicillin by a supplier.

    Product
    BIEST TD 50/50 (Estradiol USP Micronized (E2)/Estriol USP Micronized (E3)) W/V (weight /volume) 2.5 MG/ML transdermal cream, dispensed in 10 mL prefilled syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0193-2016·2015-11-18

    The Compounder Recalls Biest TD 80/20 Cream Due to Penicillin Contamination

    The Compounder is recalling Biest TD 80/20 transdermal cream because the active ingredient was contaminated with penicillin. Patients should stop using the product and consult their healthcare provider.

    Product
    BIEST TD 80/20 (estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3)) W/V (weight/volume) 2.5MG/ML Transdermal cream, dispensed in a) 3 mL and b) 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0218-2016·2015-11-18

    FDA Recalls Compounder Transdermal Cream Due to Penicillin Contamination

    The Compounder is recalling specific lots of a compounded transdermal hormone cream because the active ingredient was contaminated with penicillin.

    Product
    ESTRIOL (E3) : ESTRADIOL (E2) (Estradiol (E2) Trit (Yellow)) : PROGEST (Progesterone USP) : TESTO (Testosterone USP) W/V (weight/volume) 2 :0.1 : 30 : 0.5 MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100,
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0183-2016·2015-11-18

    FDA Recalls Compounder Biest Troches Due to Penicillin Cross-Contamination

    The Compounder is recalling Biest 80/20 troches because an active ingredient was contaminated with penicillin. Patients should stop using the product and consult their healthcare provider.

    Product
    BIEST 80/20 : PROGEST : DHEA : TESTOST (Estriol USP Micronized (E3)/Estradiol (E2) Trit (Yellow): Progesterone USP: Dehydroepiandrosterone Micronized (DHEA): Testosterone Trit ) 2.5 : 25 : 2.5 : 0.1MG TROCHE, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0206-2016·2015-11-18

    The Compounder Recalls Biest TD 80/20 Cream Due to Penicillin Contamination

    The Compounder is recalling Biest TD 80/20 transdermal cream because an active ingredient was contaminated with penicillin. Patients should stop using the product and contact their healthcare provider.

    Product
    BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG (Progesterone USP Micronized) : TESTO (Testosterone USP) W/V (weight/volume) 1.25:100:0.625 MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only,The Compounder, 340 Marshall
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0184-2016·2015-11-18

    The Compounder Recalls Biest CP 76/24 DHEA Capsules Due to Penicillin Contamination

    The Compounder is recalling Biest CP 76/24 DHEA capsules because an active ingredient was contaminated with penicillin. The recall is nationwide.

    Product
    BIEST CP 76/24: DHEA (Estriol USP Micronized (E3)/Estradiol (E2) Trit (Yellow) : Dehydroepiandrosterone Micronized (DHEA) 2.625 MG : 10 MG capsules, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0178-2016·2015-11-18

    B&B Pharmacy Recalls PAPA/PHENTO Injection Due to Sterility Concerns

    Pacific Healthcare, Inc dba B&B Pharmacy is recalling PAPA/PHENTO Injection vials because an FDA inspection found GMP violations that may affect sterility.

    Product
    PAPA/PHENTO (15mg/0.8333mg/ml) Injection, 5 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0214-2016·2015-11-18

    The Compounder Recalls Estriol Capsules Due to Penicillin Contamination

    The Compounder is recalling Estriol 4.0mg capsules because the active ingredient was contaminated with penicillin. Patients should stop using the product and consult a healthcare provider.

    Product
    ESTRIOL (E3) 4.0MG capsules, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0191-2016·2015-11-18

    The Compounder Recalls Biest TD 80/20 Transdermal Cream Due to Penicillin Contamination

    The Compounder is recalling Biest TD 80/20 transdermal cream because the active ingredient was contaminated with penicillin. This recall affects nationwide distribution.

    Product
    BIEST TD 80/20 (Estradiol USP Micronized (E2)/Estriol USP Micronized (E3)) W/V (weight /volume) 0.25 MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0198-2016·2015-11-18

    The Compounder Recalls BIEST TD 80/20 Cream Due to Penicillin Contamination

    The Compounder is recalling BIEST TD 80/20 transdermal cream because an active ingredient was contaminated with penicillin. Patients should stop using the product and contact their healthcare provider.

    Product
    BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG (Progesterone USP Micronized) : DHEA (Dehydroepiandrosterone Micronized) : TESTO (Testosterone Trit) W/V (weight/volume) VERSABASE 5.0 : 30 : 2.5 : 0.25 MG/ML Transdermal cream, dispensed in 10 mL pre
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0199-2016·2015-11-18

    The Compounder Recalls BIEST TD 80/20 Cream Due to Penicillin Contamination

    The Compounder is recalling BIEST TD 80/20 transdermal cream because an active ingredient was contaminated with penicillin. Patients should stop using the product and contact their healthcare provider.

    Product
    BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG (Progesterone USP Micronized) : DHEA (Dehydroepiandrosterone Micronized) : TESTO (Testosterone Trit) W/V (weight/volume) 2.5 : 20 : 1.25 : 0.25 MG/ML TRANSDERMAL (Cream)Transdermal cream, dispensed in
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0220-2016·2015-11-18

    FDA Recalls Estradiol and Testosterone Cream Due to Penicillin Contamination

    The Compounder is recalling Estradiol and Testosterone transdermal cream because the active ingredient was contaminated with penicillin.

    Product
    ESTRIOL (E3) : TESTO (Testosterone USP) WV (weight/volume) 0.5MG : 2MG/ML Transdermal cream, dispensed in 3 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0221-2016·2015-11-18

    The Compounder Recalls Estradiol Suppositories Due to Penicillin Contamination

    The Compounder is recalling Estradiol suppositories because the active ingredient was contaminated with penicillin. Patients should stop using the product and contact their healthcare provider.

    Product
    ESTRIOL (E3) 2.5MG suppositories, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0171-2016·2015-11-18

    PGE 20mcg/ml Injection Recalled Due to Sterility Assurance Concerns

    Pacific Healthcare, Inc dba B&B Pharmacy is recalling PGE 20mcg/ml Injection vials due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    PGE 20mcg/ml Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0207-2016·2015-11-18

    The Compounder Recalls BIEST TD 80/20 Cream Due to Penicillin Contamination

    The Compounder is recalling BIEST TD 80/20 transdermal cream because the active ingredient was contaminated with penicillin by a supplier.

    Product
    BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : TESTO (Testosterone USP) W/V (weight/volume) 1.0 :4.0 MG/ML Transdermal cream, dispensed in 3 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0200-2016·2015-11-18

    The Compounder Recalls BIEST TD 80/20 Cream Due to Penicillin Contamination

    The Compounder is recalling BIEST TD 80/20 transdermal cream because an active ingredient was contaminated with penicillin.

    Product
    BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG (Progesterone USP Micronized) : DHEA (Dehydroepiandrosterone Micronized) : TESTO (Testosterone Trit) W/V (weight/volume) VERSABASE 3: 25: 1.25: 0.25 MG/ML Transdermal cream, dispensed in 10 mL prefill
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0176-2016·2015-11-18

    B&B Pharmacy Recalls PAPA/PGE1/PHENTO Injection Due to Sterility Concerns

    B&B Pharmacy is recalling specific vials of PAPA/PGE1/PHENTO Injection because FDA inspections found GMP violations that may affect sterility.

    Product
    PAPA/PGE1/PHENTO (15mg/5mcg/0.5mg/ml) Injection, 5 mL and 10 mL vials, Rx, B & B Health Mart Pharmacy, Bellflower, CA
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0219-2016·2015-11-18

    The Compounder Recalls Estradiol and Testosterone Cream Due to Penicillin Contamination

    The Compounder is recalling specific lots of transdermal hormone cream because the active ingredient was contaminated with penicillin by a supplier.

    Product
    ESTRIOL (E3) : ESTRADIOL (E2) (Estradiol (E2) Trit (Yellow)) : TESTO (Testosterone USP) W/V (weight/volume) 2.0: 0.1: 0.5MG/ML Transdermal cream, dispensed in 5 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0175-2016·2015-11-18

    B&B Pharmacy Recalls PAPA/PGE1/PHENTO Injection Due to Sterility Concerns

    Pacific Healthcare, Inc dba B&B Pharmacy is recalling PAPA/PGE1/PHENTO Injection vials because an FDA inspection identified GMP violations that may impact product sterility.

    Product
    PAPA/PGE1/PHENTO (30mg/40mcg/1mg/ml) Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0179-2016·2015-11-18

    B&B Pharmacy Recalls PAPA/PGE1/PHENTO Injection Due to Sterility Concerns

    Pacific Healthcare, Inc dba B&B Pharmacy is recalling PAPA/PGE1/PHENTO injection vials because an FDA inspection found GMP violations that may affect sterility.

    Product
    PAPA/PGE1/PHENTO (35mg/12mcg/1.5mg/ml), Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0215-2016·2015-11-18

    The Compounder Recalls Estradiol Cream Due to Penicillin Cross-Contamination

    The Compounder is recalling Estradiol, Progesterone, and DHEA transdermal cream because the active ingredient was contaminated with penicillin.

    Product
    ESTRIOL (E3) : PROGESTERONE : DHEA (Dehydroepiandrosterone Micronized) W/V (weight/volume) VERSABASE 4.0 : 30 : 4MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0223-2016·2015-11-18

    The Compounder Recalls Estriol Cream Due to Penicillin Cross-Contamination

    The Compounder is recalling specific lots of Estriol transdermal cream because the active ingredient was contaminated with penicillin.

    Product
    ESTRIOL (E3) W/V (weight/volume) VERSABASE 3MG/ML Transdermal cream, dispensed in 5 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0172-2016·2015-11-18

    B&B Pharmacy Recalls PAPA/PGE1/PHENTO Injection Due to Sterility Concerns

    Pacific Healthcare, Inc dba B&B Pharmacy is recalling PAPA/PGE1/PHENTO injection vials because an FDA inspection identified GMP violations that may impact product sterility.

    Product
    PAPA/PGE1/PHENTO (30mg/50mcg/0.5mg/ml), Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA
    Category
    Drug
    Distribution
    2 states
  • HighNHTSA·15V769000·2015-11-18

    Micro Bird School Bus Recall for Wheelchair Lift Bearing Defect

    Micro Bird is recalling 2006-2014 school buses with Ricon wheelchair lifts where oversized pivot holes may allow bearings to shift, risking platform failure.

    Product
    MICRO BIRD — MICRO BIRD G5 SCHOOL BUS, T-SERIES SCHOOL BUS, MB II SCHOOL BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0255-2016·2015-11-18

    GE Healthcare Recalls Signa 3.0T MRI Systems Due to SAR Display Error

    GE Healthcare is recalling 19 Signa 3.0T MRI systems because displayed SAR values may be lower than actual head SAR, potentially exceeding safety limits.

    Product
    GE Healthcare, SIGNA 3.0T. Product Usage: Magnetic resonance system for diagnostic imaging. The indications for use for the 3.0T Signa VH/i (Signa 3.0T MR System) Transmit/Receive Body Imaging Coil expands the imaging capability of the 3.0T Signa VH/i MR Imaging System. The T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0259-2016·2015-11-18

    GE Healthcare Recalls Signa HDxt 3.0T MRI Scanners for SAR Limit Concerns

    GE Healthcare is recalling 215 Signa HDxt 3.0T MRI scanners because displayed SAR values may be lower than actual head SAR, potentially exceeding safety limits.

    Product
    GE Healthcare, SIGNA HDxt 3.0T. Product Usage: The 1.5T Signa HDx family and 3.0T Signa HDx family are a whole body magnetic resonance scanner for use as a diagnostic imaging device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0245-2016·2015-11-18

    Teleflex Medical Recalls Roesch Flexi-Slip Endotracheal Tube Stylets

    Teleflex Medical is recalling Roesch Flexi-Slip Endotracheal Tube Stylets because the plastic coating may split or break off.

    Product
    R¿sch Flexi-Slip Endotracheal Tube Stylet with Soft Distal Tip, Sterile, Rx only, Teleflex Medical.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0258-2016·2015-11-18

    GE Healthcare Recalls Signa HDx 3.0T MRI Scanners for SAR Display Error

    GE Healthcare is recalling 350 Signa HDx 3.0T MRI scanners because displayed SAR values may be lower than actual head SAR levels, potentially exceeding safety limits.

    Product
    GE Healthcare, SIGNA HDx 3.0T. Product Usage: The GE Signa HDx MR system is a whole body magnetic resonance scanner for use as a diagnostic imaging device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0262-2016·2015-11-18

    Philips HeartStart MRx Monitor/Defibrillator Recalled for Hardware Defects

    Philips is recalling HeartStart MRx Monitor/Defibrillators because the CO2 inlet port can become inaccessible or the handle can separate from the housing.

    Product
    Philips HeartStart MRx Monitor/Defibrillator Models:M3535A, M3536A, M3536M, M3536MC, M3536M4, M3536M5 The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the o
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0256-2016·2015-11-18

    GE Healthcare Recalls SIGNA Excite 3.0T MR Systems for SAR Display Error

    GE Healthcare is recalling 55 SIGNA Excite 3.0T MR systems because displayed SAR values may be lower than actual head SAR levels during scans.

    Product
    GE Healthcare, SIGNA Excite 3.0T. MR System for use as a diagnostic imaging device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0234-2016·2015-11-18

    Miramar Labs Recalls miraDry System for Labeling Update on Lubricant Use

    Miramar Labs is recalling 277 miraDry Systems to update labeling that reminds users to use only approved lubricants in a thin layer to prevent burns and blisters.

    Product
    miraDry System consisting of the MD4000-MC Console, the MD4000-HP miraDry Handpiece, and the MD4000-BT miraDry bioTip and accessories. General and Plastic Surgery: The miraDry System is intended for the treatment of primary axillary hyperhidrosis and was recently cleared for t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0212-2016·2015-11-18

    Boston Scientific Recalls RotaWire Elite Guidewires Due to Fracture Complaints

    Boston Scientific is recalling RotaWire Elite Guidewires and wireClip Torquer devices due to complaints of wire fracture. The devices are used with the Rotablator Rotational Atherectomy System.

    Product
    RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Device, Extra Support. REF H802233301 (5-pack outer package), REF H802233300 (single unit). The Rotablator rotational atherectomy system consists of a diamond tipped burr capable of high speed rotat
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-0211-2016·2015-11-18

    Boston Scientific Recalls RotaWire Elite Guidewires Due to Wire Fracture Complaints

    Boston Scientific is recalling RotaWire Elite Guidewires and wireClip Torquer devices because of complaints of wire fracture. The devices are used with the Rotablator Rotational Atherectomy System.

    Product
    RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Device, Floppy. REF H802223301 (5-pack outer package), REF H802223300 (single unit). The Rotablator rotational atherectomy system consists of a diamond tipped burr capable of high speed rotation des
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-0240-2016·2015-11-18

    DeRoyal Recalls Sterile Surgical Kits Due to Sterilant Exposure

    DeRoyal Industries is recalling 355 sterile surgical kits containing 3M DuraPrep solution due to unintended exposure to sterilant during package sterilization.

    Product
    DeRoyal Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical Solution, Catalog No. 8630, Lot Nos: 2016-09EE: TOTAL KNEE A & B, REF 89-4561.11; TOTAL HIP A & B, REF 89-4562.12; PODIATRY TRAY, REF 89-3101.04; KNEE SCOPE PACK, REF 89-7744.03; KNEE PACK, REF 89-819
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Drugs)·D-0210-2016·2015-11-18

    The Compounder Recalls Biest TD 86/14 Transdermal Cream Due to Penicillin Contamination

    The Compounder is recalling Biest TD 86/14 transdermal cream because the active ingredient was contaminated with penicillin. Patients should stop using the product and consult their healthcare provider.

    Product
    BIEST TD 86/14 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) IN PLO GEL (Pluronic F127 20% or Polox 20% gel) 2.9 MG/ML Transdermal cream, dispensed in 3 mL prefilled, amber syringes, Rx only,The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0250-2016·2015-11-18

    Ceterix NovoCut Suture Manager Recalled for Suture Cutting Risk

    Ceterix Orthopedics is recalling 1,364 NovoCut Suture Manager devices because they may cut sutures during knot tensioning, causing knots to unravel.

    Product
    NovoCut Suture Manager; Ceterix catalog number CTX-001. General and Plastic Surgery: Intended for use in arthroscopic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0257-2016·2015-11-18

    GE Healthcare Recalls Signa HD 3.0T MRI Systems Due to SAR Display Error

    GE Healthcare is recalling 97 Signa HD 3.0T MRI systems because displayed SAR values may be lower than actual head SAR levels, potentially exceeding safety limits.

    Product
    GE Healthcare, SIGNA HD 3.0T. Product Usage: The Signa Profile EXCITE MR system is an open, whole body scanner for use as a diagnostic imaging device. It may be utilized for imaging during interventional procedures when performed with MR compatible devices such as in-room displa
    Category
    Medical Device
    Distribution
    Distributed nationwide

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