October 2018 recalls

865 recalls were announced in October 2018.

What the numbers show

Critical: 24
Severe: 111
High: 490
Moderate: 214
Low: 26

Of the 865 recalls this month scored against our rubric, 3% are Critical, 13% are Severe.

Which agencies issued them

301–400 of 865

ModerateFDA (Devices)·Z-0192-2019·2018-10-24
Siemens Atellica IM 1300 Analyzer Software Recall for Behavioral Issues
Siemens Healthcare Diagnostics is recalling Atellica IM 1300 Analyzers with software version 1.13 and lower due to five identified behavioral issues affecting reagent locks, barcode reading, and result reporting.
Product
Atellica IM 1300 Analyzer (SMN 11066001). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0167-2019·2018-10-24
Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Defect
Zimmer Biomet is recalling 16 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The recall covers units distributed in the US and abroad.
Product
Affixus Hip Fracture Nail Left 130 11 mm x 400 mm, Item Number 814611400 Product Usage: Intended for the fixation of fractures
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0172-2019·2018-10-24
Life Technologies Recalls Gibco DPBS Due to Leaky Bottle Caps
Life Technologies is recalling 240 units of Gibco DPBS due to defective bottle caps that compromise sterility.
Product
Gibco DPBS, calcium, magnesium, for In-Vitro Diagnostic Use SKU 14040141
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0169-2019·2018-10-24
Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Defect
Zimmer Biomet is recalling 20 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The recall covers units distributed in the US and abroad.
Product
Affixus Hip Fracture Nail 125 9 mm x 165 mm, Item Number 816709165 Product Usage: Intended for the fixation of fractures
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0121-2019·2018-10-24
CryoLife Pulmonary Hemi-Artery Graft Recalled for Labeling Error
CryoLife, Inc. is recalling one CryoPatch SG Pulmonary Hemi-Artery graft because the conduit and branch lengths were switched on the product labeling.
Product
CryoPatch SG Pulmonary Hemi-Artery, 1 graft
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0034-2019·2018-10-24
Coca-Cola Bottling Company Recalls Sprite Bottles Containing Plastic Material
Coca-Cola Bottling Company is recalling Sprite 12 fl oz bottles due to the presence of plastic material. The product was distributed to six states.
Product
Sprite 12 FL OZ (355 mL) CONTAINS PHENYLALANINE CAFFEINE FREE THE COCA-COLA COMPANY FOR CONSUMER INFORMATION CALL 1-800-438-2653 UPC 0 496120 4
Category
Food
Distribution
6 states
ModerateFDA (Devices)·Z-0113-2019·2018-10-24
Siemens Recalls ADVIA Centaur CKMB Calibrator Kits Due to Potential Bias
Siemens Healthcare Diagnostics is recalling 1,870 ADVIA Centaur CKMB Calibrator kits due to a potential bias compared to internal standards.
Product
ADVIA Centaur CKMB Calibrator, Cat No. 09318028 Product Usage: For in vitro diagnostic use in calibrating ADVIA Centaur systems CKMB assays.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0035-2019·2018-10-24
Son of Italy Cheese Pizza Kits Recalled for Temperature Abuse
K.B. Pizza, Inc. is recalling Son of Italy Cheese Pizza Kits because they were left at room temperature for 24 hours.
Product
Son of Italy, Twin Pack Cheese Pizza Kit, 39 oz./2 pizzas per kit, Net Wt. 15.5 lbs. 6 pizza kits per case
Category
Food
Distribution
0 states
ModerateFDA (Drugs)·D-0056-2019·2018-10-24
FDA Recalls Best Choice Nasal Spray Due to Manufacturing Deviations
Product Quest Manufacturing LLC is recalling Best Choice Nasal Spray because it was manufactured under conditions that could impact product quality.
Product
Best Choice, 12 Hour Extra Moisturizing, Nasal Spray (Oxymetazoline Hydrochloride 0.05%), Nasal Decongestant, 1 FL OZ (30 mL) bottle, Proudly Distributed By: Valu Merchandisers, Co., 5000 Kansas Ave., Kansas City, KS 66106, UPC 0 70038 59328 7.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0132-2019·2018-10-24
Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Defects
Zimmer Biomet is recalling 27 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The recall covers units distributed in the US and abroad.
Product
Affixus Hip Fracture Nail Right 125 11 mm x 340 mm, Item Number 814311340 Product Usage: Intended for the fixation of fractures
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0144-2019·2018-10-24
Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues
Zimmer Biomet is recalling 25 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The recall covers units distributed in the US and abroad.
Product
Affixus Hip Fracture Nail Right 125 13 mm x 440 mm, Item Number 814313440 Product Usage: Intended for the fixation of fractures
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0064-2019·2018-10-24
Walgreens Severe Anefrin Nasal Spray Recalled for Quality Deviations
Product Quest Manufacturing LLC is recalling Walgreens NO DRIP Severe Anefrin Nasal Spray due to manufacturing deviations that could impact product quality.
Product
Walgreens, NO DRIP Severe Anefrin Nasal Spray (Oxymetazoline HCl 0.05%) Nasal Decongestant, Maximum Strength, 12 Hour + Menthol, 0.5 FL OZ (15 mL) bottle, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-7001-01, UPC 3 11917 18536 1.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0136-2019·2018-10-24
Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues
Zimmer Biomet is recalling 20 Affixus Hip Fracture Nails because complaints indicated the sterile packaging was already open when the product was opened in surgery.
Product
Affixus Hip Fracture Nail Right 125 11 mm x 440 mm, Item Number 814311440 Product Usage: Intended for the fixation of fractures
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0065-2019·2018-10-24
Product Quest Recalls Dr. Brandt BB Cream for Stability Failures
Product Quest Manufacturing LLC is recalling 9,480 tubes of Dr. Brandt BB Cream with SPF 30 due to failed stability specifications, including product separation.
Product
dr. brandt, BB cream with signature FLEXITONE, SPF 30, 1 oz./30 g tube, Distributed by: Cosmetic Dermatology, Inc., Miami, FL 33172, UPC 6 63963 00828 7.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0138-2019·2018-10-24
Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues
Zimmer Biomet is recalling 34 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The recall covers units distributed in the US and abroad.
Product
Affixus Hip Fracture Nail Right 125 13 mm x 180 mm, Item Number 814313180 Product Usage: Intended for the fixation of fractures
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0182-2019·2018-10-24
OriGen Dual Lumen Cannula Recalled for Manufacturing Deficiencies
OriGen Biomedical is recalling 169 units of Reinforced Dual Lumen Cannulas due to missing barium sulfate and inaccurate tip length markings.
Product
Reinforced Dual Lumen Cannula, 23Fr., REF: VV23F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as a single cannula for both venous drainage and re-infusion of blood in the internal jugular vein during extracorporeal life support procedu
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0057-2019·2018-10-24
Product Quest Recalls Best Choice Nasal Spray Due to Manufacturing Deviations
Product Quest Manufacturing LLC is recalling Best Choice 12 Hour Sinus Relief Nasal Spray because it was manufactured under conditions that could impact product quality.
Product
Best Choice, 12 Hour Sinus Relief, Nasal Spray (Oxymetazoline Hydrochloride 0.05%) Nasal Decongestant, 1 FL OZ (30 mL) bottle, Proudly Distributed By: Valu Merchandisers, Co,. 5000 Kansas Ave, Kansas City, KS 66106, UPC 0 70038 63684 7.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0146-2019·2018-10-24
Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues
Zimmer Biomet is recalling 78 Affixus Hip Fracture Nails because sterile packaging was found open during surgery.
Product
Affixus Hip Fracture Nail Left 125 9 mm x 300 mm, Item Number 814409300 Product Usage: Intended for the fixation of fractures
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0115-2019·2018-10-24
Siemens ADVIA Centaur CKMB Master Curve Material Recalled for Bias
Siemens Healthcare Diagnostics is recalling ADVIA Centaur CKMB Master Curve Material due to a potential bias identified when compared to internal standards.
Product
ADVIA Centaur CKMB Master Curve Material, Cat No. 07867768 Product Usage: For in vitro diagnostic use for evaluating the ADVIA Centaur CKMB assay. This material is intended to be run singly as unknown samples after a two-point calibration has been performed on the system.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0141-2019·2018-10-24
Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues
Zimmer Biomet is recalling 27 Affixus Hip Fracture Nails because sterile packaging was found open during surgery.
Product
Affixus Hip Fracture Nail Right 125 13 mm x 300 mm, Item Number 814313300 Product Usage: Intended for the fixation of fractures
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0126-2019·2018-10-24
Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Defects
Zimmer Biomet is recalling 51 Affixus Hip Fracture Nails because sterile packaging was found open during surgery.
Product
Affixus Hip Fracture Nail Right 125 9 mm x 340 mm, Item Number 814309340 Product Usage: Intended for the fixation of fractures
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0163-2019·2018-10-24
Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues
Zimmer Biomet is recalling 50 Affixus Hip Fracture Nails because complaints indicated the sterile packaging was already open when the products were opened in surgery.
Product
Affixus Hip Fracture Nail Right 130 13 mm x 360 mm, Item Number 814513360 Product Usage: Intended for the fixation of fractures
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0145-2019·2018-10-24
Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Defects
Zimmer Biomet is recalling 16 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The recall covers units distributed in the US and two foreign countries.
Product
Affixus Hip Fracture Nail Left 125 9 mm x 260 mm, Item Number 814409260 Product Usage: Intended for the fixation of fractures
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0123-2019·2018-10-24
Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Defect
Zimmer Biomet is recalling 24 Affixus Hip Fracture Nails because complaints indicated the sterile packaging was already open when the product was opened in surgery.
Product
Affixus Hip Fracture Nail Right 125 9 mm x 260 mm, Item Number 814309260 Product Usage: Intended for the fixation of fractures
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0153-2019·2018-10-24
Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Defects
Zimmer Biomet is recalling 68 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The recall covers units distributed in the US and two foreign countries.
Product
Affixus Hip Fracture Nail Left 125 11 mm x 360 mm, Item Number 814411360 Product Usage: Intended for the fixation of fractures
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0060-2019·2018-10-24
Walgreens Nasal Decongestant Recalled for Manufacturing Quality Deviations
Product Quest Manufacturing LLC is recalling Walgreens Nasal Spray (Oxymetazoline HCl 0.05%) due to CGMP deviations that could impact product quality.
Product
Walgreens, Nasal Spray (Oxymetazoline HCl 0.05%) Nasal Decongestant, Maximum Strength, 12 Hour, 0.75 FL OZ (22 mL) bottle, Distributed By: Walgreen Co., 200 Wilmot Road, Deerfield, IL 60015, UPC 3 11917 18622 1.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0191-2019·2018-10-24
Siemens Atellica Sample Handler Software Recall for Diagnostic Errors
Siemens Healthcare Diagnostics is recalling Atellica Sample Handler software versions 1.13 and lower due to five behavioral issues that may cause incorrect sample processing or result reporting.
Product
Atellica Sample Handler Additional (SMN 11069004). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0076-2019·2018-10-24
Rexall Sinus Nasal Pump Mist Recalled for Quality Control Issues
Product Quest Manufacturing LLC is recalling Rexall Sinus Nasal Pump Mist due to manufacturing deviations that could impact product quality.
Product
Rexall, Sinus Nasal Pump Mist, (Oxymetazoline Hydrochloride 0.05%), 1 FL OZ (30mL) bottle, SKU 00744201
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0137-2019·2018-10-24
Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues
Zimmer Biomet is recalling 18 Affixus Hip Fracture Nails because complaints indicated the sterile packaging was already open when the product was opened in surgery.
Product
Affixus Hip Fracture Nail Right 125 11 mm x 460 mm, Item Number 814311460 Product Usage: Intended for the fixation of fractures
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0034-2019·2018-10-24
CVS Saline Nasal Gel Recalled for Manufacturing Quality Deviations
Product Quest Manufacturing LLC is recalling CVS Health Saline Nasal Gel with Soothing Aloe due to manufacturing conditions that could impact product quality.
Product
CVS Health, Saline Nasal Gel with Soothing Aloe, packaged as a) Baby Net Wt. 0.5 OZ (14.2 g) tube UPC 0 50428 58392 0 Product #282476; and b) Net Wt. 0.5 OZ tube (14.2 g) UPC 0 50428 31746 4 Product #896071; Distributed by CVS Pharmacy, Inc,. One CVS Drive, Woonsocket, RI 02895.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0033-2019·2018-10-24
CVS Health Baby Nasal Spray Recalled for Manufacturing Quality Deviations
Product Quest Manufacturing LLC is recalling CVS Health Baby Nasal Spray/Drops due to manufacturing conditions that could impact product quality.
Product
CVS Health, Baby Nasal Spray/Drops, Non-Medicated, 0.5 FL OZ (15 mL) bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 29380 5 Product #459367.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0040-2019·2018-10-24
Harmon Face Values Saline Nasal Spray Recalled for Quality Deviations
Product Quest Manufacturing LLC is recalling Harmon Face Values Saline Nasal Spray due to manufacturing deviations that could impact product quality.
Product
Harmon Face Values, Saline Nasal Spray (sodium chloride), 0.65%, packaged as a) 1.5 FL OZ (44 mL) bottle UPC 7 27510 00501 0; b) 3 FL OZ (88 mL) bottle UPC 7 27510 00502 7, Distributed by Harmon Stores, Inc., Union, NJ 07083 USA.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0194-2019·2018-10-24
Siemens Atellica Analyzer Software Recall for Diagnostic Errors
Siemens is recalling Atellica Solution software version 1.13 and lower due to five behavioral issues that may cause incorrect test results or sample handling errors.
Product
Atellica CH 930 Analyzer (SMN 11067000) . The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0052-2019·2018-10-24
Thayers Saline Nasal Mist Recalled for Manufacturing Quality Deviations
Product Quest Manufacturing is recalling Thayers Saline Nasal Mist due to manufacturing conditions that could impact product quality.
Product
Thayers Natural Remedies, Saline Nasal Mist, Allergy & Sinus Relief, Slippery Elm, 3 FL OZ (89 mL) can, Distributed By: Product Quest Manufacturing, LLC, 330 Carswell Ave., Daytona Beach, FL 32117, UPC 7 27510 00659 8.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0041-2019·2018-10-24
Product Quest Recalls Meijer Saline Nasal Spray Due to Quality Deviations
Product Quest Manufacturing LLC is recalling Meijer Saline Nasal Spray because it was manufactured under conditions that could impact product quality.
Product
meijer, Saline Nasal Spray, Nasal Moisturizing Spray, packaged as a) 1.5 FL OZ (44 mL) UPC 7 08820 74428 8; b) 3FL OZ (88 mL) UPC 7 08820 74430 1, Dist. By Meijer Distribution, Inc., Grand Rapids, MI 49544 .
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0127-2019·2018-10-24
Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues
Zimmer Biomet is recalling 24 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The recall covers units distributed in the US and abroad.
Product
Affixus Hip Fracture Nail Right 125 9 mm x 360 mm, Item Number 814309360 Product Usage: Intended for the fixation of fractures
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0190-2019·2018-10-24
Siemens Atellica Sample Handler Software Recall for Diagnostic Errors
Siemens Healthcare Diagnostics is recalling Atellica Sample Handler Connect software versions 1.13 and lower due to five behavioral issues that may cause incorrect sample processing or result reporting.
Product
Atellica Sample Handler Connect (SMN 11069018). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0106-2019·2018-10-24
Helena Laboratories Recalls Mislabeled Protein S ELISA Antigen Kits
Helena Laboratories is recalling three Protein S ELISA Antigen Kits because internal components were mislabeled, causing the Substrate and Protein S Conjugate to be swapped.
Product
"Free and Total Protein S ELISA Kit" Cat. No. 5292 For use in the quantitation of free and total Protein antigen in citrated human plasma Contains: 96 Protein S: Ag Microwells, 3 x 0.5mL ELISA Reference Plasma, 1x12 mL Protein S Conjugate Solution, 1 x 60mL Sample Diluent, 1
Category
Medical Device
Distribution
0 states
ModerateFDA (Food)·F-0032-2019·2018-10-24
Coca-Cola Bottling Company Recalls Caffeine Free Diet Coke Due to Plastic Material
Coca-Cola Bottling Company is recalling Caffeine Free Diet Coke 12 oz bottles because the product contains plastic material. The recall affects shipments to six states.
Product
CAFFEINE FREE Diet Coke 12 FL OZ (355 ml) CONTAINS PHENYLALANINE CAFFEINE FREE THE COCA-COLA COMPANY FOR CONSUMER INFORMATION CALL 1-800-438-2653 UPC 0 496130 1
Category
Food
Distribution
6 states
ModerateFDA (Drugs)·D-0037-2019·2018-10-24
Product Quest Recalls DG Health Nasal Pump Mist for CGMP Deviations
Product Quest Manufacturing LLC is recalling 786,720 bottles of DG Health No Drip Nasal Pump Mist due to manufacturing deviations that could impact product quality.
Product
DG health, No Drip, Nasal Pump Mist (oxymetazoline hydrochloride), 0.05%, 1 FL OZ (30 mL) bottle, Distributed by: Dolgencorp, LLC, 100 Mission Ridge, Goodlettsville, TN 37072, UPC 7 27510 00373 3 .
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0032-2019·2018-10-24
CVS Health Sterile Saline Nasal Mist Recalled for Quality Deviations
Product Quest Manufacturing LLC is recalling CVS Health Sterile Saline Nasal Mist due to manufacturing deviations that could impact product quality.
Product
CVS Health, Sterile Saline Nasal Mist (sodium chloride) Allergy & Sinus Relief, 3.0%, 4.25 OZ (126 g) can, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 41854 3.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0049-2019·2018-10-24
QC Quality Choice Saline Nasal Gel Recalled for Quality Deviations
Product Quest Manufacturing LLC is recalling QC Quality Choice Saline Nasal Gel with Soothing Aloe due to manufacturing deviations that could impact product quality.
Product
QC Quality Choice, Saline Nasal Gel with Soothing Aloe, 0.5 OZ (14.1 g) tube, Distributed by C.D.M.A., Inc., 43157 W. Nine Mile, Novi, MI 48376-0995, UPC 6 35515 99202 3.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0109-2019·2018-10-24
FDA Recalls Ambu Aura40 Reusable Laryngeal Masks Due to Labeling Error
Besmed Health Business Corporation is recalling Ambu Aura40 Standard reusable laryngeal masks because they are packaged in pouches marked as single-use.
Product
Ambu Aura40 Standard, Reusable Laryngeal Mask Catalog Number: 340300000
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0117-2019·2018-10-24
Siemens Atellica IM CKMB Master Curve Material Recalled for Potential Bias
Siemens Healthcare Diagnostics is recalling Atellica IM CKMB Master Curve Material due to a potential bias identified when compared to internal standards.
Product
Atellica IM CKMB Master Curve Material, Cat No. 10995534 Product Usage: For in vitro diagnostic use for evaluating the ADVIA Centaur CKMB assay. This material is intended to be run singly as unknown samples after a two-point calibration has been performed on the system.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0168-2019·2018-10-24
Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues
Zimmer Biomet is recalling 10 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The recall covers units distributed in the US and abroad.
Product
Affixus Hip Fracture Nail Left 130 15 mm x 360 mm, Item Number 814615360 Product Usage: Intended for the fixation of fractures
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0036-2019·2018-10-24
K.B. Pizza Recalls Son of Italy Pizza Kits Due to Temperature Abuse
K.B. Pizza, Inc. is recalling Son of Italy pizza kits because they were left at room temperature for 24 hours.
Product
Son of Italy Pepperoni Pizza Kit ,39 oz./2 pizzas per kit, Net Wt. 15.5 lbs. 6 pizza kits per case
Category
Food
Distribution
0 states
ModerateFDA (Devices)·Z-0161-2019·2018-10-24
Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues
Zimmer Biomet is recalling 44 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The recall covers US and foreign distribution.
Product
Affixus Hip Fracture Nail Right 130 11 mm x 360 mm, Item Number 814511360 Product Usage: Intended for the fixation of fractures
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0044-2019·2018-10-24
FDA Recalls Premier Value Nasal Spray Due to Manufacturing Deviations
Product Quest Manufacturing LLC is recalling Premier Value Nasal Decongestant Extra Moisturizing Nasal Spray because it was manufactured under conditions that could impact product quality.
Product
Premier Value Nasal Decongestant Extra Moisturizing Nasal Spray (Oxymetazoline HCl 0.05%), 1 FL OZ (30 mL) bottle, Distributed By Chain Drug Consortium, 3301 NW Boca Raton Blvd, Suite 101, Boca Raton, FL 33431, NDC 68016-304-03, UPC 8 40986 01518 2.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0051-2019·2018-10-24
Rite Aid Nasal Spray Recalled for Manufacturing Quality Deviations
Product Quest Manufacturing LLC is recalling Rite Aid nasal spray due to manufacturing conditions that could impact product quality.
Product
Rite Aid Pharmacy, nasal relief NO DRIP PUMP SPRAY nasal spray, (oxymetazoline hydrochloride 0.05%), 12 Hour, 1 FL OZ (30 mL) bottle, Distributed By: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011, UPC 0 11822 31412 1.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0061-2019·2018-10-24
Walgreens NO DRIP Anefrin Nasal Spray recall due to CGMP deviations
This FDA drug recall affects Walgreens NO DRIP Anefrin nasal spray due to current good manufacturing practice deviations that could impact product quality.
Product
Walgreens, NO DRIP Anefrin Nasal Spray (Oxymetazoline HCl 0.05%), Nasal Decongestant, Extra Moisturizing, 12 Hour, 0.5 FL OZ (15 mL) bottle, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-7004-01, UPC 3 11917 18534 7.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0151-2019·2018-10-24
Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Defect
Zimmer Biomet is recalling 15 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The recall covers US and foreign distribution.
Product
Affixus Hip Fracture Nail Left 125 11 mm x 320 mm, Item Number 814411320 Product Usage: Intended for the fixation of fractures
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0035-2019·2018-10-24
CVS Health Saline Nasal Spray Recalled for Manufacturing Deviations
Product Quest Manufacturing LLC is recalling 552 bottles of CVS Health Saline Nasal Spray due to CGMP deviations that could impact product quality.
Product
CVS Health, Saline Nasal Spray, 1.5 FL OZ bottle, Distributed by CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895, Product #277790.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0189-2019·2018-10-24
Siemens Recalls Atellica Sample Handler Prime Software Due to Behavioral Issues
Siemens Healthcare Diagnostics is recalling Atellica Sample Handler Prime software versions 1.13 and lower due to five identified behavioral issues affecting diagnostic testing.
Product
Atellica Sample Handler Prime (SMN 11069001). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0128-2019·2018-10-24
Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Defects
Zimmer Biomet is recalling 19 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The recall covers units distributed in the US and abroad.
Product
Affixus Hip Fracture Nail Right 125 9 mm x 380 mm, Item Number 814309380 Product Usage: Intended for the fixation of fractures
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0133-2019·2018-10-24
Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues
Zimmer Biomet is recalling 12 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The recall covers units distributed in the US and abroad.
Product
Affixus Hip Fracture Nail Right 125 11 mm x 360 mm, Item Number 814311360 Product Usage: Intended for the fixation of fractures
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0043-2019·2018-10-24
Product Quest Recalls HuMist Saline Nasal Mist Due to Manufacturing Deviations
Product Quest Manufacturing LLC is recalling HuMist Saline Nasal Mist bottles due to manufacturing deviations that could impact product quality.
Product
HuMist Saline Nasal Mist 1.5 FL OZ (45 mL) bottle, Distributed by: Scherer Labs International, LLC. 330 Carswell Ave., Daytona Beach, FL 32117, UPC 3 02742 68045 9 .
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0142-2019·2018-10-24
Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues
Zimmer Biomet is recalling nine Affixus Hip Fracture Nails because complaints indicated the sterile packaging was already open when the products were opened in surgery.
Product
Affixus Hip Fracture Nail Right 125 13 mm x 360 mm, Item Number 814313360 Product Usage: Intended for the fixation of fractures
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0028-2019·2018-10-24
Rhinall Nasal Decongestant Recalled for Manufacturing Quality Deviations
Product Quest Manufacturing LLC is recalling Rhinall nasal drops due to CGMP deviations that could impact product quality.
Product
Rhinall (phenylephrine hydrochloride) Nasal Decongestant Nose Drops, 0.25%, 1 FL OZ (30 mL) bottle, Distributed by: Scherer Labs International, LLC., 330 Carswell Ave., Daytona Beach, FL 32117, UPC 3 02747 52531 1.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0158-2019·2018-10-24
Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Defects
Zimmer Biomet is recalling 85 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The recall covers units distributed in the US and abroad.
Product
Affixus Hip Fracture Nail 130 11 mm x 180 mm, Item Number 814511180 Product Usage: Intended for the fixation of fractures
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0075-2019·2018-10-24
Rhinall Nasal Decongestant Spray Recalled for Manufacturing Quality Deviations
Product Quest Manufacturing LLC is recalling Rhinall Nasal Decongestant Nasal Spray due to manufacturing conditions that could impact product quality.
Product
Rhinall Nasal Decongestant Nasal Spray (phenylephrine HCl), 0.25%, 1 1/3 Fl Oz. (40 ml), Manufactured for: Scherer Laboratories, Inc., Atlanta, GA 30339.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0104-2019·2018-10-24
Valeris Medical Apollo Medial Suture Anchor Recalled for Mislabeling
Valeris Medical is recalling 75 units of Apollo Medial Suture Anchors because the product was mislabeled as containing the incorrect type of suture.
Product
Valeris Medical Apollo Medial Suture Anchor, Catalog Number MSA-4515, 4.5 x 15mm, each package contains (1) PEEK Screw, (1) #2 ForceBraid Blue, and (1) #2 ForceBraid White, 5 packages per container, Sterile, Rx. The firm name on the label is Valeris Medical, Marietta, GA.
Category
Medical Device
Distribution
4 states
ModerateFDA (Drugs)·D-0046-2019·2018-10-24
Premier Value Sterile Saline Nasal Mist Recalled for Quality Concerns
Product Quest Manufacturing LLC is recalling 10,584 cans of Premier Value Sterile Saline Nasal Mist due to manufacturing deviations that could impact product quality.
Product
Premier Value, Sterile Saline Nasal Mist, Saline Nasal Moisturizer (0.9% Sodium Chloride) Solution, 4.25 FL OZ (126 mL) can, Distributed By Chain Drug Consortium, 3301 NW Boca Raton Blvd, Suite 101, Boca Raton, FL 33431, NDC 8 40986 02998 1.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0124-2019·2018-10-24
Affixus Hip Fracture Nails Recalled Due to Compromised Sterile Packaging
The FDA is recalling 72 Affixus Hip Fracture Nails because sterile packaging was found open during surgery, creating a potential contamination risk.
Product
Affixus Hip Fracture Nail Right 125 9 mm x 300 mm, Item Number 814309300 Product Usage: Intended for the fixation of fractures
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0130-2019·2018-10-24
Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues
Zimmer Biomet is recalling 20 Affixus Hip Fracture Nails because complaints indicated the sterile packaging was already open when the product was opened in surgery.
Product
Affixus Hip Fracture Nail Right 125 9 mm x 460 mm, Item Number 814311460 Product Usage: Intended for the fixation of fractures
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0022-2019·2018-10-24
Humco Recalls Thyroid USP Powder Due to Inconsistent Active Ingredient Levels
Humco Holding Group, Inc. is recalling specific lots of Thyroid, USP (Porcine) powder because the levels of active ingredients are inconsistent.
Product
Thyroid, USP (Porcine) Levothyroxine 36.3 mcg/grain Liothyronine 9.7 mcg/grain Active Pharmaceutical Ingredient Rx Only 1000 grams NDC 0395-8077-43 Packaged by: Humco Texarkana, TX 75501
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0165-2019·2018-10-24
Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues
Zimmer Biomet is recalling 14 Affixus Hip Fracture Nails because complaints indicated the sterile packaging was already open when the product was opened in surgery.
Product
Affixus Hip Fracture Nail Left 130 11 mm x 360 mm, Item Number 814611360 Product Usage: Intended for the fixation of fractures
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0082-2019·2018-10-24
Teva Recalls Clonazepam Tablets Due to Failed Stability Specifications
Teva Pharmaceuticals is recalling 1,373 cartons of Clonazepam Orally Disintegrating Tablets because routine stability testing revealed out-of-specification water content.
Product
Clonazepam Orally Disintegrating Tablets USP, 2 mg., 60-count carton. RX only. Teva Pharmaceuticals USA, INC. North Whales, PA 19454. NDC 0555-0098-96
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0024-2019·2018-10-24
Humco Recalls Thyroid Powder Due to Inconsistent Active Ingredient Levels
Humco Holding Group, Inc. is recalling 10 kilograms of Thyroid, USP powder because it has inconsistent levels of levothyroxine and liothyronine.
Product
Thyroid, USP (Full Strength) Levothyroxine 112.1 mcg/grain Liothyronine 29.2 mcg/grain Active Pharmaceutical Ingredient Rx Only 1000 grams NDC 0395-6580-43 Packaged by: Humco Texarkana, TX 75501 USA
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0080-2019·2018-10-24
Product Quest Recalls Family Dollar Saline Nasal Spray for Quality Issues
Product Quest Manufacturing LLC is recalling Family Dollar Saline Nasal Spray due to manufacturing deviations that could impact product quality.
Product
Family Dollar Saline Nasal Spray 4.25 oz. can, 24 pk, SKU 0900562.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0079-2019·2018-10-24
Finafta Baby Oral Gel Recalled for Manufacturing Quality Deviations
Product Quest Manufacturing LLC is recalling Finafta Baby Oral Gel because it was manufactured under conditions that could impact product quality.
Product
Finafta Baby, Oral Gel (benzocaine 7.5%), 7.1 Grams (0.25 Oz.) tube, Distributed By: Efficient Laboratories, Inc., Miami, FL 33166.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0119-2019·2018-10-24
Cypress Medical Recalls McKesson Insulin Syringes Due to Suction Defect
Cypress Medical Products LLC is recalling 400 cases of McKesson Insulin Syringes because a small hole impedes liquid suction.
Product
McKesson Insulin Syringe 0.3mL 31GX5/16 Item Numbers: 102-SN310C31516P Product Usage: Indication of Use: Injection of U-100 insulin only.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0176-2019·2018-10-24
Terumo Advanced Perfusion System 1 Electronic Patient Gas System Recall
Terumo is recalling 152 Advanced Perfusion System 1 Electronic Patient Gas Systems because the service manual was not updated for software version 1.30.
Product
Terumo¿ Advanced Perfusion System 1 Electronic Patient Gas System, Catalog#: 801188
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0110-2019·2018-10-24
GE Healthcare MRI Systems Recalled for Potential Image Flipping and Data Mismatch
GE Medical Systems is recalling 5,200 MRI systems with software version 11.x because service activities may have failed to reinstall the latest software, potentially causing flipped images or patient data mismatches.
Product
GE Healthcare MRI Systems, Software Version 11.x, sold under the following product names: 1.5T CXK4 LCC MAGNET,1.5T EXCITE, 1.5T EXCITE E/S, 1.5T EXCITE GS, 1.5T EXCITE HYBRID, 1.5T EXCITE TWIN, 1.5T EXCITE UPGRAD, 1.5T HD ES/HS TR W/EXCITE, 1.5T MR MOBILE (SERIAL # R350),
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0048-2019·2018-10-24
Premier Value Saline Nasal Spray Recalled for Quality Concerns
Product Quest Manufacturing LLC is recalling Premier Value Saline Nasal Spray due to manufacturing deviations that could impact product quality.
Product
Premier Value, Saline Nasal Spray, Sodium Chloride 0.65%, packaged as a) 3 FL OZ (88 mL) bottle NDC 68016-388-00 UPC 8 40986 01483 3; b) 1.5 FL OZ (44 mL) bottle NDC 68016-466-00 UPC 8 40986 01482 6, Distributed By Chain Drug Consortium, 3301 NW Boca Raton Blvd, Suite 101, Boca R
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0180-2019·2018-10-24
OriGen Biomedical Recalls Reinforced Dual Lumen Cannulas Due to Deficiencies
OriGen Biomedical is recalling 452 units of Reinforced Dual Lumen Cannulas due to missing barium sulfate and incorrect tip length markings.
Product
Reinforced Dual Lumen Cannula, 16Fr., REF: VV16F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as a single cannula for both venous drainage and re-infusion of blood in the internal jugular vein during extracorporeal life support procedu
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0036-2019·2018-10-24
Saline Nasal Spray Recalled for Manufacturing Quality Deviations
Product Quest Manufacturing LLC is recalling Discount Drug Mart and Food Fair Saline Nasal Spray due to manufacturing deviations that could impact product quality.
Product
Discount Drug Mart, Food Fair, Saline Nasal Spray (sodium chloride) 0.65%, packaged as a) 3 FL OZ (89 mL) bottle UPC 0 93351 01833 6; b) 1.5 FL OZ (45 mL) bottle UPC 0 93351 01834 3, Distributed by: Discount Drug Mart, 211 Commerce Drive, Medina, OH 44256
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0077-2019·2018-10-24
Rexall Nasal Spray Recalled for Manufacturing Quality Deviations
Product Quest Manufacturing LLC is recalling Rexall Extra Moisturizing No Drip Nasal Spray due to CGMP deviations that could impact product quality.
Product
Rexall, Extra Moisturizing No Drip Nasal Spray (Oxymetazoline Hydrochloride 0.05%) 1 FL OZ (30 mL) bottle, 48/3/1 #12687901 w/ Silo
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0055-2019·2018-10-24
Product Quest Recalls OCEAN Saline Nasal Spray Due to Quality Deviations
Product Quest Manufacturing LLC is recalling OCEAN Saline Nasal Spray bottles nationwide because they were manufactured under conditions that could impact product quality.
Product
OCEAN Saline Nasal Spray, packaged in a) 3.5 Fl. Oz. (104 mL) bottle UPC 3 01875 26001 9; b) 45 cc (1.5 fl. oz.) UPC 3 01875 26003 3, c) Buddy Pack containing one 1.5 FL. OZ. (44 mL) and one 0.76 FL.OZ. (22 mL) bottle per carton, Distributed by: Valeant Consumer Products, A Divis
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0067-2019·2018-10-24
Rite Aid First Aid Antibiotic Ointment Recalled for Low Bacitracin Zinc
Product Quest Manufacturing LLC is recalling Rite Aid First Aid Antibiotic Ointment because the bacitracin zinc ingredient was found to be subpotent.
Product
Rite Aid Pharmacy, First Aid Antibiotic Ointment, (neomycin sulfate 3.5 mg, polymyxin B sulfate 5,000 units, bacitracin zinc 400 units per gram), 2 OZ (56 g) tube, Distributed By: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011, UPC 0 11822 55441 1.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0150-2019·2018-10-24
Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues
Zimmer Biomet is recalling 33 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The devices were distributed nationwide and in Chile and the Netherlands.
Product
Affixus Hip Fracture Nail Left 125 11 mm x 260 mm, Item Number 814411260 Product Usage: Intended for the fixation of fractures
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0162-2019·2018-10-24
Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues
Zimmer Biomet is recalling 20 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The recall covers units distributed in the US and abroad.
Product
Affixus Hip Fracture Nail Right 130 11 mm x 400 mm, Item Number 814511400 Product Usage: Intended for the fixation of fractures
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0078-2019·2018-10-24
Rexall Nasal Spray Recalled for Manufacturing Quality Deviations
Product Quest Manufacturing LLC is recalling Rexall Extra Moisturizing No Drip Nasal Spray due to manufacturing conditions that could impact product quality.
Product
Rexall, Extra Moisturizing No Drip Nasal Spray (Oxymetazoline Hydrochloride 0.05%) 1 FL OZ (30 mL) bottle, 48 pk. (12687901)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0038-2019·2018-10-24
Product Quest Recalls Saline Nasal Mist Due to Manufacturing Deviations
Product Quest Manufacturing LLC is recalling 46,056 cans of FAMILY wellness Sterile Saline Nasal Mist because they were manufactured under conditions that could impact product quality.
Product
FAMILY wellness, Sterile Saline, Nasal Mist, Saline Nasal Relief (0.9% Sodium Chloride Solution), 4.25 FL OZ (126 mL) can, Distributed by: Midwood Brands, LLC, 10611 Monroe Rd., Matthews, NC 28105, UPC 0 32251 11617 9.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0023-2019·2018-10-24
Humco Recalls Thyroid Powder Due to Inconsistent Active Ingredient Levels
Humco Holding Group, Inc. is recalling Thyroid, USP (Porcine) powder because it has inconsistent levels of levothyroxine and liothyronine.
Product
Thyroid, USP (Porcine) Levothyroxine 36.3 mcg/grain Liothyronine 9.7 mcg/grain Active Pharmaceutical Ingredient Rx Only 100 grams NDC 0395-8077-62 Packaged by: Humco Texarkana, TX 75501 USA
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0140-2019·2018-10-24
Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Defect
Zimmer Biomet is recalling 22 Affixus Hip Fracture Nails because sterile packaging was found open during surgery.
Product
Affixus Hip Fracture Nail Right 125 13 mm x 280 mm, Item Number 814313280 Product Usage: Intended for the fixation of fractures
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0059-2019·2018-10-24
Product Quest Recalls Best Choice Saline Nasal Spray for Quality Deviations
Product Quest Manufacturing LLC is recalling Best Choice Saline Nasal Spray because it was manufactured under conditions that could impact product quality.
Product
Best Choice, SALINE Nasal Spray (Sodium Chloride 0.65% Phenylcarbinol & Benzalkonium Chloride as Preservatives), 1.5 FL OZ (44 mL) bottle, Proudly Distributed By: Valu Merchandisers, Co., 5000 Kansas Ave, Kansas City, KS 66106, UPC 0 70038 58487 2.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0033-2019·2018-10-24
Coca-Cola Bottling Company Recalls Diet Coke for Plastic Contamination
Coca-Cola Bottling Company is recalling Diet Coke 12 fl oz bottles because the product contains plastic material. The recall affects shipments to six states.
Product
NO SUGAR NO CALORIES Diet Coke 12 FL OZ (355 mL) CONTAINS PHENYLALANINE CAFFEINE FREE THE COCA-COLA COMPANY FOR CONSUMER INFORMATION CALL 1-800-438-2653 UPC 0 495940 3
Category
Food
Distribution
6 states
ModerateFDA (Devices)·Z-0143-2019·2018-10-24
Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues
Zimmer Biomet is recalling 10 units of Affixus Hip Fracture Nails because complaints indicated the sterile packaging was already open when the product was opened in surgery.
Product
Affixus Hip Fracture Nail Right 125 13 mm x 400 mm, Item Number 814313400 Product Usage: Intended for the fixation of fractures
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0047-2019·2018-10-24
FDA Recalls Premier Value Nasal Decongestant Spray Due to Quality Concerns
Product Quest Manufacturing LLC is recalling Premier Value Nasal Decongestant Nasal Spray because it was manufactured under conditions that could impact product quality.
Product
Premier Value, Nasal Decongestant, Nasal Spray (oxymetazoline HCl 0.05%), Regular Strength, 1 FL OZ (30 mL) bottle, Distributed By Chain Drug Consortium, 3301 NW Boca Raton Blvd, Suite 101, Boca Raton, FL 33431, NDC 68016-316-03, UPC 8 40986 01516 8.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0054-2019·2018-10-24
TopCare Saline Nasal Gel Recalled for Manufacturing Quality Deviations
Product Quest Manufacturing LLC is recalling TopCare Saline Nasal Gel with Soothing Aloe due to manufacturing conditions that could impact product quality.
Product
TopCare, Saline Nasal Gel with Soothing Aloe, 0.5 OZ (14 g) tube, Distributed By Topco Associates LLC, Elk Grove Village, IL 60007, UPC 0 36800 42146 2.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0030-2019·2018-10-24
CVS Health Saline Nasal Mist Recalled for Quality Control Issues
Product Quest Manufacturing LLC is recalling CVS Health Sterile Saline Nasal Mist due to manufacturing deviations that could impact product quality.
Product
CVS Health, Sterile Saline Nasal Mist (sodium chloride) Saline Nasal Moisturizer, 0.9%, packaged in a) Net Wt. 1.52 OZ (43 g) can UPC 0 50428 37079 7 Product #896831; b) Net Wt. 4.25 OZ (120 g) can UPC 0 50428 36124 5; c) Children's Net Wt. 2 OZ (57 g) can UPC 0 50428 58685 3 Pro
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0073-2019·2018-10-24
CVS Triple Antibiotic Ointment Spray Recalled for Low Bacitracin Zinc Levels
Product Quest Manufacturing LLC is recalling CVS Health Triple Antibiotic Ointment Spray because the bacitracin zinc ingredient was found to be subpotent.
Product
CVS Health, Original Strength, Triple Antibiotic Ointment Spray (bacitracin zinc 400 units, neomycin sulfate 3.5 mg, polymyxin B sulfate 5,000 units per gram), 2 OZ (57 g) can, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, Product#957603, UPC 0 50428 29
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0058-2019·2018-10-24
FDA Recalls Best Choice Nasal Spray Due to Manufacturing Quality Issues
Product Quest Manufacturing LLC is recalling 3,600 bottles of Best Choice Nasal Spray because they were manufactured under conditions that could impact product quality.
Product
Best Choice, 12 Hour No-Drip Nasal Spray (Oxymetazoline Hydrochloride 0.05%) Nasal Decongestant, 1 FL OZ (30 mL) bottle, Proudly Distributed By: Valu Merchandisers, Co., 5000 Kansas Ave, Kansas City, KS 66106, UPC 0 70038 59895 4.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0068-2019·2018-10-24
FDA Recalls Premier Value Muscle Rub Due to High Menthol Levels
Product Quest Manufacturing LLC is recalling Premier Value Fast Relief Muscle Rub because the menthol ingredient exceeded specification limits.
Product
Premier Value, Fast Relief, Muscle Rub, (menthol 10% and methyl salicylate 15%) 4 OZ (113 g) tube, Distributed By: Chain Drug Consortium, 3301 NW Boca Raton Blvd., Suite 101, Boca Raton, FL, 33431, UPC 8 40986 01341
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0107-2019·2018-10-24
Baxter Spectrum IQ Infusion System Recalled for Programming Error
Baxter is recalling Spectrum IQ Infusion Systems because a software error prevents operators from programming certain infusions.
Product
SPECTRUM IQ INFUSION SYSTEM WITH DOSE IQ SAFETY SOFTWARE, 3570009
Category
Medical Device
Distribution
1 state
ModerateFDA (Food)·F-0031-2019·2018-10-24
Tropical Nut & Fruit Company Recalls United Fitness Mix Due to Maggots
Tropical Nut & Fruit Company is recalling United Fitness Mix 25LB boxes after a customer reported finding maggots in the product.
Product
United Fitness Mix 25LB box, Almonds, Walnuts, Pumpkin Seeds, Cashews, Blueberries***Manufactured or packed in a facility that uses tree nuts, peanuts, milk, soy, and wheat products" Distributed by: Truly Good Foods, Orlando, FL 32811 UPC 0 94154 00803 7
Category
Food
Distribution
1 state
ModerateFDA (Devices)·Z-0114-2019·2018-10-24
Siemens ADVIA Centaur CKMB Calibrator Recalled for Potential Bias
Siemens Healthcare Diagnostics is recalling 69 kits of ADVIA Centaur CKMB Calibrator 2-pack Japan due to a potential bias identified compared to internal standards.
Product
ADVIA Centaur CKMB Calibrator 2-pack Japan, Cat No. 02562748 Product Usage: For in vitro diagnostic use in calibrating ADVIA Centaur systems CKMB assays.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0050-2019·2018-10-24
Product Quest Recalls QC Quality Choice Saline Nasal Spray for CGMP Deviations
Product Quest Manufacturing LLC is recalling QC Quality Choice Saline Nasal Spray due to manufacturing deviations that could impact product quality.
Product
QC Quality Choice, Saline Nasal Relief, Moisturizing Nasal Spray, Sodium Chloride 0.65%, packaged as a) 1.5 FL OZ (45 mL) bottle UPC 6 35515 98845 3; b) 3 FL OZ (89 mL) bottle UPC 6 35515 95042 9, Distributed by C.D.M.A., Inc., 43157 W. Nine Mile, Novi, MI 48376-0995.
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0025-2019·2018-10-24
Mylan Recalls Levonorgestrel and Ethinyl Estradiol Tablets Due to Labeling Errors
Mylan Pharmaceuticals is recalling specific lots of levonorgestrel and ethinyl estradiol tablets because the blister packs display incorrect NDC and product name information.
Product
Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg/0.03 mg, Rx Only, 3 extended-cycle blister packs containing 91 tablets each, Made in India, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-7281-53.
Category
Drug
Distribution
0 states
LowFDA (Drugs)·D-0069-2019·2018-10-24
Well at Walgreens Scar Cream Recalled for Low Active Ingredient Levels
Product Quest Manufacturing LLC is recalling 6,516 tubes of Well at Walgreens Scar Cream with SPF 30 because the octocrylene and avobenzone levels were found to be lower than required.
Product
Well at Walgreens, Scar Cream with SPF 30, (Avobenzone 3%, Octocrylene 10%, Oxybenzone 6%), 0.7 OZ (19.8 g) tube, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, UPC 3 11917 18281 0.
Category
Drug
Distribution
Distributed nationwide

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