The Recall Desk

Archive

February 2019 recalls

610 recalls were announced in February 2019.

What the numbers show

Critical
67
Severe
179
High
200
Moderate
148
Low
16

Of the 610 recalls this month scored against our rubric, 11% are Critical, 29% are Severe.

201–300 of 610

  • HighNHTSA·19V121000·2019-02-22

    Mercedes-Benz Recalls 2019 Sprinter VS30 for Rear Fog Light Defect

    Daimler Vans USA is recalling 2019 Mercedes-Benz Sprinter VS30 vehicles because the LED rear fog lights may fail to illuminate, increasing crash risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ SPRINTER (VS30)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalUSDA FSIS·017-2019·2019-02-21

    J Bar B Foods Recalls Smoked Sausage for Undeclared Milk Allergen

    J Bar B Foods is recalling ready-to-eat smoked sausage products because they contain milk, a known allergen, that is not declared on the label.

    Product
    J Bar B Foods — J Bar B Foods Recalls Ready-To-Eat Smoked Sausage Products due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·19V103000·2019-02-21

    Ford Transit Hybrid Driveshaft Recall Due to Detachment Risk

    XL Hybrids is recalling 2015-2018 Ford Transit vehicles modified with their electric hybrid system because the front driveshaft may detach, increasing crash risk.

    Product
    FORD — FORD TRANSIT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V107000·2019-02-21

    Mack Trucks Recalls Pinnacle and Anthem Models for Brake Tank Defect

    Mack Trucks is recalling certain Pinnacle and Anthem vehicles because undersized air brake supply tanks may reduce braking performance and increase crash risk.

    Product
    MACK — MACK PINNACLE (CHU), PINNACLE (CXU), ANTHEM (AN)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V098000·2019-02-21

    Isuzu Reach Recall: Front Driveshaft Joint May Fail

    XL Hybrids is recalling 2013-2018 Isuzu Reach vehicles with electric hybrid systems because the front driveshaft joint may fail, risking loss of drive power and crashes.

    Product
    ISUZU — ISUZU REACH
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V117000·2019-02-21

    GM Recalls 2019 Cadillac CT6 for Turn Signal Switch Defect

    General Motors is recalling 2019 Cadillac CT6 vehicles because turn signals may not automatically cancel, potentially misleading other road users.

    Product
    CADILLAC — CADILLAC CT6
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V116000·2019-02-21

    Winnebago Metro Link Recall for Wheelchair Lift Cam Failure

    Winnebago is recalling 2014 Metro Link vehicles because a wheelchair lift cam may fail, causing the platform to rise too high and increasing injury risk.

    Product
    WINNEBAGO — WINNEBAGO METRO LINK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·19070·2019-02-21

    Shearwater Recalls Yellow Diving Transmitters Due to Drowning Hazard

    Shearwater is recalling yellow diving pressure transmitters because they may fail to signal tank pressure, posing a drowning hazard to divers.

    Product
    Shearwater yellow diving pressure transmitters
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·19069·2019-02-21

    SRAM Recalls Bicycle Gear Hubs Due to Brake Failure and Injury Hazards

    SRAM is recalling i-Motion 3 internal gear hubs because the brakes can fail, posing crash and injury hazards to riders.

    Product
    SRAM i-Motion 3 internal gear hubs (coaster brake version) for bicycles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·19V118000·2019-02-21

    Prevost Recalls 2015-2018 Coaches Due to Fire Suppression Defect

    Prevost is recalling 2015-2018 coaches and motorhomes because the fire extinguisher actuator may fail to discharge the suppression agent, increasing injury risk in a fire.

    Product
    PREVOST — PREVOST H3-45, X3-45, X3-45 VIP, H3-45 VIP
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0932-2019·2019-02-20

    Oskri Almond Coconut Butter Recalled for Listeria Risk

    Oskri Corp. is recalling Almond Coconut Butter due to potential Listeria monocytogenes contamination. The recall was expanded to include all Oskri manufactured butters.

    Product
    Almond Coconut Butter, packaged in 16 oz. plastic jars, UPC 66016-40188 Oskri, 528 E. Tyranena Park Rd, Lake Mills, WI 53551. .
    Category
    Food
    Distribution
    21 states
  • CriticalFDA (Food)·F-0869-2019·2019-02-20

    Diamond Crystal Recalls Cheesecake Mix Due to Salmonella Risk

    Diamond Crystal Brands is recalling specific lots of no-bake cheesecake mix because an ingredient is potentially contaminated with Salmonella.

    Product
    Cheesecake mix packaged in the following ways: 1) Chef's Companion New York Style, No-Bake Cheesecake, Distributed by Diamond Crystal Brands, Inc. Savannah, GA, in paper pouches, 6 per case; 2) Classic Sysco, New York Style No-Bake Cheesecake Mix, Net Wt. 4 lbs, Distributed
    Category
    Food
    Distribution
    41 states
  • CriticalFDA (Food)·F-0907-2019·2019-02-20

    Thrive Market Organic Crunchy Almond Butter Recalled for Listeria Risk

    Thrive Market is recalling Organic Crunchy Almond Butter due to potential Listeria monocytogenes contamination. The product was sold nationwide via website.

    Product
    Thrive Market Organic Crunchy Almond Butter 16 oz. SKU/UPC 671635704764
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0921-2019·2019-02-20

    Oskri Organic Peanut Honey Sea Salt Butter Recalled for Listeria Risk

    Oskri Corp. is recalling Organic Peanut Honey Sea Salt Butter due to potential Listeria monocytogenes contamination. The recall was expanded to include all Oskri manufactured butters.

    Product
    Organic Peanut Honey Sea Salt Butter, packaged in 16 oz. Plastic jars UPC 66016-40072, pouches UPC 66016-40161. Oskri, 528 E. Tyranena Park Rd, Lake Mills, WI 53551.
    Category
    Food
    Distribution
    21 states
  • CriticalFDA (Food)·F-0912-2019·2019-02-20

    Thrive Market Creamy Cashew Butter Recalled for Listeria Risk

    Thrive Market is recalling Creamy Cashew Butter due to potential Listeria monocytogenes contamination. All unexpired lots are affected.

    Product
    Thrive Market Creamy Cashew Butter 16 oz. SKU/UPC 671635704801
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0871-2019·2019-02-20

    Gordon Choice Vanilla Instant Pudding Recalled for Salmonella Risk

    Diamond Crystal Brands is recalling Gordon Choice Vanilla Instant Pudding & Pie Filling because an ingredient is potentially contaminated with Salmonella.

    Product
    Gordon Choice, Vanilla Instant Pudding & Pie Filling, Net Wt. 24 OZ, For Distribution Exclusively by Gordon Food Service, Wyoming, MI in paper pouches, 12 per case.
    Category
    Food
    Distribution
    41 states
  • CriticalFDA (Food)·F-0917-2019·2019-02-20

    Oskri Organic Peanut Butter Recalled for Listeria Contamination Risk

    Oskri Corp. is recalling specific lots of Organic Peanut Butter due to potential Listeria monocytogenes contamination. The recall was expanded to include all Oskri manufactured butters.

    Product
    Organic Peanut Butter, packaged in 16 oz. plastic jars, or pouches. Oskri, 528 E. Tyranena Park Rd, Lake Mills, WI 53551. Creamy UPC 66016-31628, Crunchy UPC 66016-31646, Pouch Creamy UPC 66016-40159.
    Category
    Food
    Distribution
    21 states
  • CriticalFDA (Food)·F-0931-2019·2019-02-20

    Oskri Hazelnut Cacao Spread Butter Recalled for Listeria Risk

    Oskri Corp. is recalling Hazelnut Cacao Spread Butter due to potential Listeria monocytogenes contamination. The recall was expanded to include all Oskri manufactured butters.

    Product
    Hazelnut Cacao Spread Butter, packaged in 16 oz. plastic jars UPC 66016-40113, or pouches UPC 66016-40160. Oskri, 528 E. Tyranena Park Rd, Lake Mills, WI 53551. .
    Category
    Food
    Distribution
    21 states
  • CriticalFDA (Food)·F-0926-2019·2019-02-20

    Oskri Cashew Coconut Butter Recalled for Listeria Risk

    Oskri Corp. is recalling Cashew Coconut Butter due to potential Listeria monocytogenes contamination. The recall was expanded to include all Oskri manufactured butters.

    Product
    Cashew Coconut Butter, packaged in 16 oz. plastic jars, or pouches. Oskri, 528 E. Tyranena Park Rd, Lake Mills, WI 53551. 16 oz jar UPC 66016-40114, Pouch UPC 66016-40169. .
    Category
    Food
    Distribution
    21 states
  • CriticalFDA (Food)·F-0934-2019·2019-02-20

    Oskri Organic Coconut Butter Recalled for Listeria Risk

    Oskri Corp. is recalling Organic Coconut Butter due to potential Listeria monocytogenes contamination. The recall was expanded to include all Oskri manufactured butters.

    Product
    Organic Coconut Butter, packaged in 16 oz. plastic jars, UPC 66016-40190 Oskri, 528 E. Tyranena Park Rd, Lake Mills, WI 53551. .
    Category
    Food
    Distribution
    21 states
  • CriticalFDA (Food)·F-0865-2019·2019-02-20

    FDA Recalls Chef's Companion Chocolate Pudding for Salmonella Risk

    Diamond Crystal Brands is recalling Chef's Companion Chocolate Instant Pudding & Pie Filling because an ingredient is potentially contaminated with Salmonella.

    Product
    Chef's Companion Chocolate Instant Pudding & Pie Filling, Net Wt. 24 OZ, Distributed By Diamond Crystal Brands, Inc. Savannah, GA, in paper pouches 12 per case.
    Category
    Food
    Distribution
    41 states
  • CriticalFDA (Food)·F-0864-2019·2019-02-20

    Chef's Companion Lemon Instant Pudding Recalled for Salmonella Risk

    Diamond Crystal Brands is recalling Chef's Companion Lemon Instant Pudding & Pie Filling because it was manufactured with an ingredient potentially contaminated with Salmonella.

    Product
    Chef's Companion Lemon Instant Pudding & Pie Filling, Net Wt. 24 OZ, Distributed By Diamond Crystal Brands, Inc. Savannah, GA, in paper pouches, 12 per case.
    Category
    Food
    Distribution
    41 states
  • CriticalFDA (Food)·F-0861-2019·2019-02-20

    FDA Recalls Butterscotch Pudding Mix Due to Salmonella Risk

    Diamond Crystal Brands is recalling Culinary Secrets Butterscotch Instant Pudding Mix because an ingredient is potentially contaminated with Salmonella.

    Product
    Culinary Secrets, Butterscotch Instant Pudding Mix, Net Wt. 28 OZ, Marketed by Independent Marketing Alliance, Houston, TX, in paper pouches 12 per case
    Category
    Food
    Distribution
    41 states
  • CriticalFDA (Food)·F-0909-2019·2019-02-20

    Thrive Market Organic Crunchy Peanut Butter Recalled for Listeria Risk

    Thrive Market is recalling Organic Crunchy Peanut Butter due to potential Listeria monocytogenes contamination. The product was sold nationwide through the company's website.

    Product
    Thrive Market Organic Crunchy Peanut Butter 16 oz. SKU/UPC 671635704788
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0933-2019·2019-02-20

    Oskri Organic Peanut Coconut Butter Recalled for Listeria Risk

    Oskri Corp. is recalling Organic Peanut Coconut Butter due to potential Listeria monocytogenes contamination. The recall was expanded to include all Oskri manufactured butters.

    Product
    Organic Peanut Coconut Butter, packaged in 16 oz. plastic jars, UPC 66016-40189 Oskri, 528 E. Tyranena Park Rd, Lake Mills, WI 53551. .
    Category
    Food
    Distribution
    21 states
  • CriticalFDA (Food)·F-0923-2019·2019-02-20

    Oskri Peanut Butter Mixed Berry Recalled for Listeria Contamination Risk

    Oskri Corp. is recalling Peanut Butter Mixed Berry due to potential Listeria monocytogenes contamination. The recall was expanded to include all Oskri manufactured butters.

    Product
    Peanut Butter Mixed Berry, packaged in 16 oz. Plastic jars, UPC 66016-40191. Oskri, 528 E. Tyranena Park Rd, Lake Mills, WI 53551.
    Category
    Food
    Distribution
    21 states
  • CriticalFDA (Food)·F-0928-2019·2019-02-20

    Oskri Organic Pumpkin Seed Butter Recalled for Listeria Risk

    Oskri Corp. is recalling Organic Pumpkin Seed Butter due to potential Listeria monocytogenes contamination. The recall was expanded to include all Oskri manufactured butters.

    Product
    Organic Pumpkin Seed Butter, packaged in 16 oz. plastic jars UPC 66016-31684. Oskri, 528 E. Tyranena Park Rd, Lake Mills, WI 53551. .
    Category
    Food
    Distribution
    21 states
  • CriticalFDA (Food)·F-0862-2019·2019-02-20

    Diamond Crystal Chocolate Pudding Mix Recalled for Salmonella Risk

    Diamond Crystal Brands is recalling chocolate instant pudding and pie filling mix because an ingredient is potentially contaminated with Salmonella.

    Product
    Chocolate instant pudding and pie filling mix packaged in the following ways: 1) Classic Sysco Chocolate Instant Pudding & Pie Filling Mix, Net Wt. 24 OZ, Distributed by Sysco Corporation, Houston, TX, in paper pouches, 12 per case; 2) Classic Sysco Chocolate Instant Puddin
    Category
    Food
    Distribution
    41 states
  • CriticalFDA (Food)·F-0867-2019·2019-02-20

    Diamond Crystal Recalls Chocolate Pudding Mix Due to Salmonella Risk

    Diamond Crystal Brands is recalling specific chocolate instant pudding and pie filling products because they were manufactured with an ingredient potentially contaminated with Salmonella.

    Product
    Chocolate instant pudding and pie filling packaged in the following ways: 1) Chef's Companion Sugar Free, Reduced Calorie, Instant Chocolate Pudding & Pie Filling, Net Wt. 5 OZ, Distributed By Diamond Crystal Brands, Inc. Savannah, GA, in paper pouches, 12 per case; 2) Mona
    Category
    Food
    Distribution
    41 states
  • CriticalFDA (Food)·F-0918-2019·2019-02-20

    Oskri Organic Peanut Espresso Butter Recalled for Listeria Risk

    Oskri Corp. is recalling Organic Peanut Espresso Butter due to potential Listeria monocytogenes contamination. The recall was expanded to include all Oskri manufactured butters.

    Product
    Organic Peanut Espresso Butter, packaged in 16 oz. plastic jars, UPC 66016-40110. Oskri, 528 E. Tyranena Park Rd, Lake Mills, WI 53551.
    Category
    Food
    Distribution
    21 states
  • CriticalFDA (Food)·F-0920-2019·2019-02-20

    Oskri Organic Peanut Chia Flax Butter Recalled for Listeria Risk

    Oskri Corp. is recalling Organic Peanut Chia Flax Butter due to potential Listeria monocytogenes contamination. The recall was expanded to include all Oskri manufactured butters.

    Product
    Organic Peanut Chia Flax Butter, packaged in 16 oz. Plastic jars, UPC 66016-40109. Oskri, 528 E. Tyranena Park Rd, Lake Mills, WI 53551.
    Category
    Food
    Distribution
    21 states
  • CriticalFDA (Food)·F-0914-2019·2019-02-20

    Thrive Market Sunflower Butter Recalled for Potential Listeria Contamination

    Thrive Market is recalling 16 oz. Sunflower Butter due to potential Listeria monocytogenes contamination. The product was sold nationwide through the company's website.

    Product
    Thrive Market Sunflower Butter 16 oz. SKU/UPC 671635704825
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0910-2019·2019-02-20

    Thrive Market Peanut Butter Recalled for Potential Listeria Contamination

    Thrive Market is recalling Organic Creamy Peanut Butter due to potential Listeria monocytogenes contamination. The recall covers all unexpired lots sold nationwide.

    Product
    Thrive Market Organic Creamy Peanut Butter 16 oz. SKU/UPC 671635704771
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0868-2019·2019-02-20

    Chef's Companion Chocolate Pudding Recalled for Salmonella Risk

    Diamond Crystal Brands is recalling Chef's Companion Sugar Free Chocolate Pudding because an ingredient may be contaminated with Salmonella.

    Product
    Chef's Companion Sugar Free, Reduced Calorie, Instant Chocolate Pudding & Pie Filling, Net Wt. 3.5 OZ, Distributed By Diamond Crystal Brands, Inc. Savannah, GA, in paper pouches 12 per case;
    Category
    Food
    Distribution
    41 states
  • CriticalFDA (Food)·F-0924-2019·2019-02-20

    Oskri Recalls Almond Butter for Potential Listeria Contamination

    Oskri Corp. is recalling specific almond butter products due to potential Listeria monocytogenes contamination. The recall was expanded to include all Oskri-manufactured butters.

    Product
    Almond Butter, packaged under the following brand and sizes: - Wholesome Pantry Organic Creamy Salted 16 oz. Plastic jars UPC 04119006004. - Wholesome Pantry Organic Creamy Unsalted UPC 04119006005. - Oskri branded 16 oz. plastic jars or pouches. Oskri, 528 E. Tyranena Par
    Category
    Food
    Distribution
    21 states
  • CriticalFDA (Food)·F-0915-2019·2019-02-20

    Oskri Organic Sunflower Butter Recalled for Listeria Risk

    Oskri Corp. is recalling Organic Sunflower Butter due to potential Listeria monocytogenes contamination. The recall was expanded to include all Oskri manufactured butters.

    Product
    Organic Sunflower Butter, Net Wt. 16 oz. (453g) Packaged under the following brand names: 1. Thrive Market, UPC 71635-70482. Manufactured for: Thrive Market - 4509 Glencoe Ave, Marina Del Rey, CA 90292. 2. Oskri, UPC 66016-40129 Oskri, 528 E. Tyranena Park Rd, Lake M
    Category
    Food
    Distribution
    21 states
  • CriticalFDA (Food)·F-0872-2019·2019-02-20

    HomeFresh Suya Barbecue Seasoning Recalled for Undeclared Peanuts

    Ellgof Inc. is recalling HomeFresh Suya Barbecue Seasoning because it contains undeclared peanuts. The product was distributed in Massachusetts and New York.

    Product
    HomeFresh FOODS Suya Barbecue Seasoning, UPC: 6 033000120298, Net Wt: 240g/0.53 lbs; Produced in Ghana by: ELSSY KESS COMPANY LTD GHANA
    Category
    Food
    Distribution
    2 states
  • CriticalFDA (Food)·F-0930-2019·2019-02-20

    Oskri Organic Tahini Butter Recalled for Listeria Risk

    Oskri Corp. is recalling Organic Tahini Butter due to potential Listeria monocytogenes contamination. The recall was expanded to include all Oskri manufactured butters.

    Product
    Organic Tahini Butter, packaged in 16 oz. plastic jars UPC 66016-31629, or pouches UPC 66016-40163. Oskri, 528 E. Tyranena Park Rd, Lake Mills, WI 53551.
    Category
    Food
    Distribution
    21 states
  • CriticalFDA (Food)·F-0897-2019·2019-02-20

    BlendTech Recalls Seasoning Blend Due to Potential Salmonella Contamination

    BlendTech, Inc. is recalling JB's Bun Blend 2.0 seasoning because it contains an ingredient potentially contaminated with Salmonella.

    Product
    JB s Bun Blend 2.0, BT-1181811, Blend Tech Inc. Wichita, KS, packaged in 50 lb bags.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0929-2019·2019-02-20

    Oskri Organic Sunflower Butter Recalled for Listeria Risk

    Oskri Corp. is recalling specific lots of Organic Sunflower Butter due to potential Listeria monocytogenes contamination. The recall was expanded to include all Oskri manufactured butters.

    Product
    Organic Sunflower Butter, packaged under the following Brands. - Wholesome Pantry Organic Unsalted Sunflower Butter 16 oz. plastic jars UPC 04119005827. - Oskri branded 16 oz plastic jar UPC 66016-31630. Oskri, 528 E. Tyranena Park Rd, Lake Mills, WI 53551.
    Category
    Food
    Distribution
    21 states
  • SevereFDA (Drugs)·D-0436-2019·2019-02-20

    Promise Pharmacy Recalls Prednisolone Ophthalmic Solution for Sterility Concerns

    Promise Pharmacy is recalling compounded Prednisolone and Gatifloxacin and Bromfenac ophthalmic solution due to lack of sterility assurance. The recall covers 900 bottles distributed nationwide.

    Product
    Prednisolone and Gatifloxacin and Bromfenac, Ophthalmic Solution, 1%/0.5%/0.09%, Combo Drops 3 mL, Rx Only, Compounded Prescription, Promise Pharmacy 31818 US Hwy 19N, Palm Harbor FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0455-2019·2019-02-20

    Promise Pharmacy Recalls Ipamorelin Injections Due to Sterility Concerns

    Promise Pharmacy is recalling 93 vials of Ipamorelin injections nationwide due to a lack of sterility assurance.

    Product
    Ipamorelin, 15mg, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0434-2019·2019-02-20

    Promise Pharmacy Recalls Prednisolone and Gatifloxacin Ophthalmic Solution for Sterility Concerns

    Promise Pharmacy is recalling compounded Prednisolone and Gatifloxacin ophthalmic solution due to a lack of sterility assurance.

    Product
    Prednisolone and Gatifloxacin and Ketorolac Ophthalmic Solution 1%/0.5%/0.5%, Combo Drops: 3 mL Rx Only, Compounded Prescription, Promise Pharmacy 31818 US Hwy 19N, Palm Harbor FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0485-2019·2019-02-20

    Dr. Reddy's Recalls Levetiracetam Injection Due to Labeling Error

    Dr. Reddy's Laboratories is recalling Levetiracetam Injection bags because the primary label incorrectly identifies the product strength and sodium chloride concentration.

    Product
    LEVETIRACETAM — LEVETIRACETAM (LEVETIRACETAM INJECTION)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0927-2019·2019-02-20

    Oskri Cashew Butter Recalled for Potential Listeria Contamination

    Oskri Corp. is recalling specific lots of cashew butter due to potential Listeria monocytogenes contamination. The recall was expanded to include all Oskri manufactured butters.

    Product
    Cashew Butter, packaged under the following brands and sizes: - Wholesome Pantry Organic Cashew Butter UPC 04119006006. - Oskri Branded 16 oz. plastic jars UPC 66016-31647. Oskri, 528 E. Tyranena Park Rd, Lake Mills, WI 53551.
    Category
    Food
    Distribution
    21 states
  • SevereFDA (Drugs)·D-0480-2019·2019-02-20

    Promise Pharmacy Recalls Zinc Sulfate Injection Due to Sterility Concerns

    Promise Pharmacy is recalling three vials of Zinc Sulfate injection due to a lack of sterility assurance. The product was distributed nationwide.

    Product
    Zinc Sulfate,10mg/ml injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0922-2019·2019-02-20

    Oskri Organic Peanut Butter Recalled for Potential Listeria Contamination

    Oskri Corp. is recalling Organic Peanut Spicy Cayenne Butter due to potential Listeria monocytogenes contamination. The recall was expanded to include all Oskri manufactured butters.

    Product
    Organic Peanut Spicy Cayenne Butter, packaged in 16 oz. Plastic jars UPC 66016-40111, pouches UPC 66016-40164. Oskri, 528 E. Tyranena Park Rd, Lake Mills, WI 53551.
    Category
    Food
    Distribution
    21 states
  • SevereFDA (Drugs)·D-0452-2019·2019-02-20

    Promise Pharmacy Recalls Ipamorelin Injection Due to Sterility Concerns

    Promise Pharmacy is recalling 927 vials of Ipamorelin+Modified GRF 1-29 injection because of a lack of sterility assurance.

    Product
    Ipamorelin+Modified GRF 1-29, 9 mg/5mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0466-2019·2019-02-20

    Promise Pharmacy Recalls ICB-Complex Injections Due to Sterility Concerns

    Promise Pharmacy is recalling 846 vials of ICB-Complex injection nationwide due to a lack of sterility assurance.

    Product
    ICB-Complex, injection,Inositol/Choline/B1/B2/B3/B5/B6/B12/Leucine/Carnitine/Chromium/Lidocaine: 25mg/25mg/5mg/2.5mg/25mg/5mg/5mg/0.1mg/1.5mg/25mg/25mg/10mg/ML, 10ml, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0469-2019·2019-02-20

    Promise Pharmacy Recalls Niacinamide Injection Due to Sterility Concerns

    Promise Pharmacy, LLC is recalling Niacinamide injection, 100mg/mL, 5mL vials due to a lack of sterility assurance. The product was distributed nationwide in the USA.

    Product
    Niacinamide injection, 100mg/mL, 5mL vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0809-2019·2019-02-20

    Medtronic SENSIA Dual Chamber Pacemaker Recall for Circuit Error

    Medtronic is recalling SENSIA dual chamber pacemakers due to a potential circuit error that may affect device functionality when programmed to specific modes.

    Product
    Medtronic implantable pulse generator: SENSIA, Dual chamber pacemaker (DDD): (a) Model Number SED01 (b) Model Number SEDR01 (c) Model Number SEDRL1
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0460-2019·2019-02-20

    Promise Pharmacy Recalls HCG Injections Due to Sterility Concerns

    Promise Pharmacy is recalling 654 vials of HCG injections nationwide due to a lack of sterility assurance.

    Product
    HCG, Human chorionic gonadotropin 11,000 units, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0493-2019·2019-02-20

    Tris Pharma Recalls Infants' Ibuprofen Due to Higher Concentration

    Tris Pharma is recalling specific lots of Infants' Ibuprofen because the medication may contain a higher concentration of ibuprofen than labeled.

    Product
    Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye Free, Non-staining Berry Flavor, 0.5 FL OZ (15 mL) bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 39338 3, NDC 59779-925-23.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0443-2019·2019-02-20

    Promise Pharmacy Recalls Methylcobalamin Injections Due to Sterility Concerns

    Promise Pharmacy, LLC is recalling 704 vials of Methylcobalamin 10,000 mcg Injection due to a lack of sterility assurance. The product was distributed nationwide in the USA.

    Product
    Methylcobalamin lyophilized, 10,000 mcg Injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0458-2019·2019-02-20

    Promise Pharmacy Recalls Bremelanotide Injections Due to Sterility Concerns

    Promise Pharmacy is recalling 64 vials of Bremelanotide 20mg injections nationwide due to a lack of sterility assurance.

    Product
    Bremelanotide (PT 141), 20mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0495-2019·2019-02-20

    Tris Pharma Recalls Superpotent Infants' Ibuprofen Suspension

    Tris Pharma is recalling 35,280 bottles of Infants' Ibuprofen due to potential higher-than-labeled ibuprofen concentrations.

    Product
    Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye Free, Non-staining Berry Flavor, 1 FL OZ (30 mL) bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 39961 3, NDC 50428-1252-4.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0467-2019·2019-02-20

    Promise Pharmacy Recalls MIC B12 Injection Due to Sterility Concerns

    Promise Pharmacy, LLC is recalling MIC B12+L-Carnitine+Chromium injections due to a lack of sterility assurance. The recall covers 64 vials distributed nationwide.

    Product
    MIC B12+L-Carnitine+Chromium injection, Methionine Inositol Choline Methylcobalamin+L-Carnitine+Chromium, 25mg/50mg/50mg/1mg/100mg/0.4mcg/ml, 10mL, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·19E013000·2019-02-20

    MORryde Rubber Pin Box Recall for Improperly Torqued Bolts

    MORryde is recalling certain Rubber Pin Boxes because mounting bolts may have been improperly torqued, which could cause the trailer to detach from the tow vehicle.

    Product
    EQUIPMENT:MECHANICAL recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0478-2019·2019-02-20

    Promise Pharmacy Recalls Dexpanthenol Injection Vials Due to Sterility Concerns

    Promise Pharmacy, LLC is recalling 7 vials of Dexpanthenol Injection due to a lack of sterility assurance. The product was distributed nationwide in the USA.

    Product
    Dexpanthenol, 250mg/mL Injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0473-2019·2019-02-20

    Promise Pharmacy Recalls Trim Calm Vials Due to Sterility Concerns

    Promise Pharmacy is recalling 7 vials of Trim Calm due to a lack of sterility assurance. The product was distributed nationwide in the USA.

    Product
    Trim Calm, GABA/Magnesium/Taurine/Theanine, 50mg/50mg/50mg/50mg/ml, 10mL vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0440-2019·2019-02-20

    Promise Pharmacy Recalls Vitamin D3 Injections Due to Sterility Concerns

    Promise Pharmacy is recalling specific lots of Vitamin D3 50,000iu/mL injections nationwide due to a lack of sterility assurance.

    Product
    Vitamin D3 50,000iu/mL, injection 5 mL, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0432-2019·2019-02-20

    Promise Pharmacy Recalls Prednisolone and Moxifloxacin Eye Drops for Sterility Concerns

    Promise Pharmacy is recalling 43 bottles of compounded Prednisolone and Moxifloxacin ophthalmic solution due to a lack of sterility assurance.

    Product
    Prednisolone and Moxifloxacin Ophthalmic Solution 1%/0.5%, Combo Drops 3 mL, Rx Only, Compounded Prescription, Promise Pharmacy 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0494-2019·2019-02-20

    Tris Pharma Recalls Superpotent Infant Ibuprofen Suspension

    Tris Pharma is recalling specific lots of infant ibuprofen suspension because the medication may contain higher concentrations than labeled.

    Product
    infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, Dye-Free Berry Flavor, 1 FL OZ (30 mL) bottle, Distributed by Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-125-24.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0449-2019·2019-02-20

    Promise Pharmacy Recalls Sermorelin Injections Due to Sterility Concerns

    Promise Pharmacy, LLC is recalling 255 vials of Sermorelin 9 mg injection nationwide due to a lack of sterility assurance.

    Product
    Sermorelin 9 mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0902-2019·2019-02-20

    Bundle Organics Chocolate-Maca Snack Bars Recalled for Mold Presence

    1908 Brands is recalling Bundle Organics Chocolate-Maca snack bars due to the presence of mold. The recall affects 2,534 bars distributed to one consignee.

    Product
    Bundle Organics Bar Chocolate-Maca, 1.9 Oz snack bar, Ambient storage
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0453-2019·2019-02-20

    Promise Pharmacy Recalls Ipamorelin Injections Due to Sterility Concerns

    Promise Pharmacy is recalling 416 vials of Ipamorelin 9 mg injection because the product lacks sterility assurance. The affected lots were distributed nationwide.

    Product
    Ipamorelin, 9 mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0464-2019·2019-02-20

    Promise Pharmacy Recalls IGF-1-LR3 Injections Due to Sterility Concerns

    Promise Pharmacy, LLC is recalling 59 vials of IGF-1-LR3, 3 mg injection due to a lack of sterility assurance. The product was distributed nationwide in the USA.

    Product
    IGF-1-LR3, 3 mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0468-2019·2019-02-20

    Promise Pharmacy Recalls Nicotinamide Adenine Dinucleotide Injections Due to Sterility Concerns

    Promise Pharmacy, LLC is recalling specific lots of Nicotinamide Adenine Dinucleotide injections due to a lack of sterility assurance. The affected products were distributed nationwide in the USA.

    Product
    Nicotinamide Adenine Dinucleotide, 0.5 mg, injection, 10mL vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0860-2019·2019-02-20

    Salmon River Foods Recalls Forest Wild Dark Chocolate Bars for Undeclared Milk

    Salmon River Foods is recalling Forest Wild Dark Chocolate bars due to undeclared milk. The product was distributed in Massachusetts and Wisconsin.

    Product
    The Forest Wild Collection Dark Chocolate bar, CB15052, net wt. 1.25 oz per bar. Product is packaged in a card board box of 12 individually wrapped chocolate bars. Dream Chocolate brand, UPC on each bar is 6 76181 15088 1. Label has the wolf image. The label is read in parts:
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0439-2019·2019-02-20

    Promise Pharmacy Recalls Multi Trace Injection Due to Sterility Concerns

    Promise Pharmacy is recalling Multi Trace injection vials because they may lack sterility assurance. The recall covers 30 mL vials distributed nationwide.

    Product
    Multi Trace, Zinc/Copper/Manganese/Selenium 5mg/1mg/0.5mg/60mcg/ml, injection 30 mL, Rx Only, Compounded Prescription, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0445-2019·2019-02-20

    Promise Pharmacy Recalls Glutathione Injection Due to Sterility Concerns

    Promise Pharmacy, LLC is recalling specific lots of Glutathione Injection because of a lack of sterility assurance. The affected products were distributed nationwide.

    Product
    Glutathione Injection, 200 mg/mL, 10 mL, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0459-2019·2019-02-20

    Promise Pharmacy Recalls BPC 157 Injections Due to Sterility Concerns

    Promise Pharmacy is recalling 37 vials of BPC 157 injections because they lack sterility assurance. The affected lot was distributed nationwide.

    Product
    BPC 157, 10mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0462-2019·2019-02-20

    Promise Pharmacy Recalls HCG Injections Due to Sterility Concerns

    Promise Pharmacy is recalling 819 vials of HCG injections nationwide due to a lack of sterility assurance.

    Product
    HCG, Human chorionic gonadotropin 2,000 units, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0438-2019·2019-02-20

    Promise Pharmacy Recalls Vitamin B Complex Vials Due to Sterility Concerns

    Promise Pharmacy is recalling 204 vials of compounded Vitamin B Complex due to a lack of sterility assurance. The product was distributed nationwide.

    Product
    Vitamin B Complex, Dexpanthenol/Leucine/Niacinamide/Pyridoxine/Riboflavin/Thiamine 2 mg/2.5 mg/25 mg/ 25 mg/ 2 mg/ 25 mg/mL 10 mL vial, Rx Only, Compounded Prescription, Promise Pharmacy Compounding Specialists, 31818 US Hwy 19N, Palm Harbor FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0474-2019·2019-02-20

    Promise Pharmacy Recalls Procaine HCl Injection Due to Sterility Concerns

    Promise Pharmacy, LLC is recalling 11 vials of Procaine HCl 2% injection due to a lack of sterility assurance. The product was distributed nationwide.

    Product
    Procaine HCl, 2% injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0454-2019·2019-02-20

    Promise Pharmacy Recalls Ipamorelin and Sermorelin Injections Due to Sterility Concerns

    Promise Pharmacy is recalling 139 vials of Ipamorelin and Sermorelin injections nationwide due to a lack of sterility assurance.

    Product
    Ipamorelin+Sermorelin, 15mg/15mg, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0450-2019·2019-02-20

    Promise Pharmacy Recalls Sermorelin Injection Due to Sterility Concerns

    Promise Pharmacy is recalling 341 vials of Sermorelin/GHRP2/GHRP6 injection because the product lacks sterility assurance. The recall covers lots distributed nationwide in the USA.

    Product
    Sermorelin/GHRP2/GHRP6, 9 mg/9 mg/9 mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V114000·2019-02-20

    Audi Recalls 2019 Models for Front Shock Absorber Cracks

    Audi is recalling 2019 Q7, Q8, S5, and S5 Cabriolet vehicles because front shock absorber forks may crack, potentially impairing steering and increasing crash risk.

    Product
    AUDI — AUDI Q8, Q7, S5 CABRIOLET, S5
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0448-2019·2019-02-20

    Promise Pharmacy Recalls Sermorelin Theanine/GHRP2 Injection Due to Sterility Concerns

    Promise Pharmacy is recalling Sermorelin Theanine/GHRP2 injections due to a lack of sterility assurance. The affected lot was distributed nationwide.

    Product
    Sermorelin Theanine/GHRP2, 15 mg/75 mg/5.4 mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0447-2019·2019-02-20

    Promise Pharmacy Recalls Thymosin Beta-4 Injections Due to Sterility Concerns

    Promise Pharmacy is recalling 94 vials of Thymosin Beta-4, 15 mg Injection due to a lack of sterility assurance. The product was distributed nationwide in the USA.

    Product
    Thymosin Beta-4, 15 mg Injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0444-2019·2019-02-20

    Promise Pharmacy Recalls Amino Blend Injection Due to Sterility Concerns

    Promise Pharmacy is recalling 158 vials of Amino Blend Injection because the product lacks sterility assurance. The recall covers lots distributed nationwide.

    Product
    Amino Blend Injection, Ornithine/Arginine/Lysine/Lidocaine 75 mg/75 mg/75 mg/10 mg/mL 10 mL, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0446-2019·2019-02-20

    Promise Pharmacy Recalls Ascorbic Acid Injection Due to Sterility Concerns

    Promise Pharmacy, LLC is recalling 196 vials of Ascorbic Acid Injection due to a lack of sterility assurance. The product was distributed nationwide.

    Product
    Ascorbic Acid, Compounded-Tapioca, 450 mg/mL Injection, 50 mL, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0441-2019·2019-02-20

    Promise Pharmacy Recalls Trim Complete Injection Due to Sterility Concerns

    Promise Pharmacy is recalling 158 vials of Trim Complete injection nationwide due to a lack of sterility assurance.

    Product
    Trim Complete, Methlonine/Inositol/Choline/Thiamine/Riboflavin/Niacinamide Dexpanthenol/Pyridoxine/Methylcobalamin/Leucine/Chromium 25 mg/50 mg/50 mg/25 mg/2.5 mg/25 mg/2 mg/25 mg/0.5 mg2.5 mg/1.33 mcg/mL injection 10 mL, Rx Only, Promise Pharmacy Compounding Specialists 31818 US
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0451-2019·2019-02-20

    Promise Pharmacy Recalls Sermorelin Injection Due to Sterility Concerns

    Promise Pharmacy is recalling 296 vials of Sermorelin/GHRP2/GHRP6 injection due to a lack of sterility assurance. The product was distributed nationwide.

    Product
    Sermorelin/GHRP2/GHRP6 6mg/3mg/3mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0457-2019·2019-02-20

    Promise Pharmacy Recalls Epithalon Injections Due to Sterility Concerns

    Promise Pharmacy, LLC is recalling Epithalon 15mg injections due to a lack of sterility assurance. The affected lots were distributed nationwide.

    Product
    Epithalon, 15mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0463-2019·2019-02-20

    Promise Pharmacy Recalls Sermorelin Injections Due to Sterility Concerns

    Promise Pharmacy is recalling 266 vials of Sermorelin 15mg injections because they lack sterility assurance. The products were distributed nationwide.

    Product
    Sermorelin, 15mg, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V113000·2019-02-20

    Porsche Recalls 718 Models for Potential Fuel Leak Fire Risk

    Porsche is recalling 2017-2019 718 Boxster and Cayman vehicles because a crossmember may detach in a crash, causing a fuel leak that increases fire risk.

    Product
    PORSCHE — PORSCHE 718 CAYMAN, 718 BOXSTER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0431-2019·2019-02-20

    Promise Pharmacy Recalls Acetylcysteine Ophthalmic Solution Due to Sterility Concerns

    Promise Pharmacy, LLC is recalling 75 bottles of Acetylcysteine Ophthalmic Solution because the product lacks sterility assurance. The recall covers nationwide distribution in the USA.

    Product
    Acetylcysteine Ophthalmic Solution, 100mg/ml, 10%, Rx only, Promise Pharmacy Compounding Specialist, 31818 US Hwy 19N, Palm Harbor FL 34684.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0477-2019·2019-02-20

    Promise Pharmacy Recalls Lysine HCl Injection Due to Sterility Concerns

    Promise Pharmacy, LLC is recalling 11 vials of Lysine HCl injection due to a lack of sterility assurance. The affected lot was distributed nationwide.

    Product
    Lysine HCl, 100 mg/mL injection, 10ml, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0479-2019·2019-02-20

    Promise Pharmacy Recalls Glycyrrhizic Acid Injection Due to Sterility Concerns

    Promise Pharmacy, LLC is recalling specific lots of Glycyrrhizic Acid Injection because of a lack of sterility assurance. The affected product was distributed nationwide.

    Product
    Glycyrrhizic Acid, 8mg/mL Injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0435-2019·2019-02-20

    Promise Pharmacy Recalls Prednisolone Ophthalmic Solution Due to Sterility Concerns

    Promise Pharmacy is recalling compounded Prednisolone and Gatifloxacin and Bromfenac Ophthalmic Solution due to a lack of sterility assurance.

    Product
    Prednisolone and Gatifloxacin and Bromfenac Ophthalmic Solution, 1%/0.5%/0.09%, Combo Drops 6 mL, Rx Only, Compounded Prescription, Promise Pharmacy 31818 US Hwy 19N, Palm Harbor FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0821-2019·2019-02-20

    Elekta MOSAIQ Oncology System Recalled for Potential Radiation Dose Errors

    Elekta is recalling MOSAIQ Oncology Information Systems because missing wedge IDs may cause patients to receive higher radiation doses than planned.

    Product
    MOSAIQ¿ Oncology Information System and Sequencer MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0472-2019·2019-02-20

    Promise Pharmacy Recalls Folic Acid Injection Due to Sterility Concerns

    Promise Pharmacy, LLC is recalling Folic Acid Injection, 10 mg/mL, 10mL vials due to a lack of sterility assurance. The affected lots were distributed nationwide.

    Product
    Folic Acid, Injection, 10 mg/mL, 10mL vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0481-2019·2019-02-20

    Promise Pharmacy Recalls Folic Acid Injection Due to Sterility Concerns

    Promise Pharmacy is recalling Folic Acid 5mg/ml injections because the product lacks sterility assurance. The recall covers nationwide distribution.

    Product
    Folic Acid, 5mg/ml injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0471-2019·2019-02-20

    Promise Pharmacy Recalls Zinc Sulfate Injection Due to Sterility Concerns

    Promise Pharmacy, LLC is recalling specific lots of Zinc Sulfate injection due to a lack of sterility assurance. The product was distributed nationwide.

    Product
    Zinc Sulfate, 5mg/mL injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0437-2019·2019-02-20

    Promise Pharmacy Recalls Prednisolone and Bromfenac Ophthalmic Solution for Sterility Concerns

    Promise Pharmacy is recalling 167 bottles of compounded Prednisolone and Bromfenac Ophthalmic Solution due to a lack of sterility assurance.

    Product
    Prednisolone and Bromfenac Ophthalmic Solution, 1%/0.09% Combo Drops 3 mL, Rx Only, Compounded Prescription, Promise Pharmacy 31818 US Hwy 19N, Palm Harbor FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0465-2019·2019-02-20

    Promise Pharmacy Recalls Melanotan II Injections Due to Sterility Concerns

    Promise Pharmacy is recalling 43 vials of Melanotan II injections because the product lacks sterility assurance. The affected lots were distributed nationwide.

    Product
    Melanotan II, 10mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide

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