Class I - Dangerous
cGMP Deviations.
🏥
Over-the-Counter
💊 Drugs • 328 recalls
Class I - Dangerous
cGMP Deviations.
Childrens Dimetapp Cold & Cough, For ages 6 yrs. & over, 8 FL OZ. bottle, (237 mL), Distributed by: Pfizer Madison, NJ 07940, Made in Canada, UPC: 60300312234196, NDC: 0031-2234-19.
Glaxosmithkline Consumer Healthcare Holdings
Class I - Dangerous
Defective Delivery System: the dosing cups are missing graduations applicable to certain age groups.
Gaviscon Regular Strength Liquid Antacid Cool Mint, 12 FL OZ (355 mL), Distributed by: GSK Consumer Healthcare Warren, NJ 07059, NDC 0135-0094-41
Glaxosmithkline Consumer Healthcare Holdings
Class I - Dangerous
Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label.
Gaviscon Extra Strength Liquid Antacid Extra Strength Cherry, 12 FL OZ. (355 mL), Distributed by: GSK Consumer Healthcare Warren, NJ 07059, NDC 0135-0574-41
Glaxosmithkline Consumer Healthcare Holdings
Class I - Dangerous
Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label.
Gaviscon Liquid Antacid Extra Strength, Cool Mint, 12 FL OZ (355 mL) single pack and twin pack, Distributed by: GSK Consumer Healthcare Warren, NJ 07059, NDC 0135-0095-41
Glaxosmithkline Consumer Healthcare Holdings
Class I - Dangerous
Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label.
Gaviscon Regular Strength Liquid Antacid Cool Mint, 6 FL OZ (177 mL), Distributed by: GSK Consumer Healthcare Warren, NJ 07059, NDC 0135-0094-42
Glaxosmithkline Consumer Healthcare Holdings
Class I - Dangerous
Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label.
Maximum Strength Lidocaine Cold & Hot Patch (lidocaine 4%, menthol 1%), 5 patches per box, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895; NDC 66902-218-05.
Wuhan Bingbing Pharmaceutical Co.
Class I - Dangerous
CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date.
LidoPatch (lidocaine HCl 3.6%, menthol 1.25%) Pain Relief Patch, packaged in 1 patch/box (NDC 10882-527-01); 30 patches/box (NDC 10882-527-02 and 10882-527-04), Manufactured for: JAR Laboratories, Elmhurst, IL.
Wuhan Bingbing Pharmaceutical Co.
Class I - Dangerous
CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date.
Advil Sinus Congestion and Pain/Advil Allergy and Congestion Relief 8 pc with $1 IRC (mixed product display - only Advil Allergy & Congestion is impacted). NDC # 0573-2161-14 SKU# F00573216114A (original lot # R73995) Co-packaged Batch/Lot # 0045DB, 9327VB, 0017DA & 9353WA
Glaxosmithkline Consumer Healthcare Holdings
Class I - Dangerous
Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
Rompe Pecho CF Cold & Flu with Honey, 6 FL. Oz (178 mL) bottle, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166.UPC 0 00856 33106 8
Efficient Laboratories
Class I - Dangerous
Microbial Contamination of Non-Sterile Products
Equate Eye Allergy Relief Drops, W-M item #: 567371432 Package Size: 15 mL, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-874-13
Altaire Pharmaceuticals
Class I - Dangerous
Lack of Assurance of Sterility
Natural Ophthalmics Allergy Desensitization Eye Drops, 15 mL, NDC 68770-120-15
Altaire Pharmaceuticals
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
Microbial Contamination of Non-Sterile Products: products were found to be contaminated and above specification for lidocaine assay.
Class I - Dangerous
Superpotent Drug: products were found to be contaminated and above specification for lidocaine assay.
Class I - Dangerous
Microbial Contamination of Non-Sterile Products: products were found to be contaminated and above specification for lidocaine assay.
Class I - Dangerous
Superpotent Drug: products were found to be contaminated and above specification for lidocaine assay.
Class I - Dangerous
Superpotent Drug: products were found to be contaminated and above specification for lidocaine assay.
Class I - Dangerous
Superpotent Drug: products were found to be contaminated and above specification for lidocaine assay.
CRYO-273 Cold Pain Relieving Gel 128 FL. OZ. Distributed By: CRYO-273.com Tampa, FL 33629. UPC 8 15290 01550 2
US Pharmaceuticals
Class I - Dangerous
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.