Drugs & Medicine Recalls
Pharmaceutical recall notices, chemical impurities, and biological contamination.
Testosterone, 62.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmi...
Presence of Foreign substance - potential presence of metal particulate matter
Green Lumber Natural Fuel For Men capsule, packaged in 2, 4, 10, and 30-count bl...
Marketed without an Approved NDA/ANDA: FDA analysis found this product to contain tadalafil
Rheumacare capsules, 30 count bottle, Mfg in India by: Virgo UAP Pharma Pvt. Ltd...
CGMP Deviations: product found to contain lead.
Trazodone Hydrochloride, USP, 50 mg, 100-Count Bottle, Rx only, Manufactured by:...
Presence of Foreign Tablets/Capsules
Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, 100-co...
cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
Diclofenac Sodium, Topical Gel, 3%, 100 g tube, Rx only, Mfd. by: Taro Pharmaceu...
Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%.
Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxte...
Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution
parodontax (cetylpyridinium chloride)ACTIVE GUM HEALTH, Mouthwash, Mint. Net Wt ...
Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for missing or illegible lot and expiration date coding on the bottles.
Glycopyrrolate Oral Solution, 1 mg/5 mL, 16 oz. (473 mL), Rx only, Manufactured ...
Failed Impurities/Degradation Specifications
methylprednisolone tablets, USP Dosepak, 4 mg, 1 Blister Card per Carton contain...
Labeling: Not Elsewhere Classified. Incorrect orientation of the blister foil applied to the blister cavities, which results in incorrect dosing information when following the directions on the foil.
INON ACE Antacid tablets (magnesium aluminosilicate, magnesium hydroxide and sim...
Failed Disintegration Specifications: above the time expected.
Furosemide Tablets, USP 40 mg, 1,000 Tablets, Rx Only, Manufactured for: Rising ...
Presence of Foreign Substance
Diclofenac Sodium Topical Gel, 1%, NET WT 100 g (3.53 oz), Manufactured by: DPT ...
Failed PH Specifications
Thyroid, USP, Rx only, Net Wt: 0.50kg, For Manufacturing, Processing or Repackag...
Subpotent Drug
Icosapent Ethyl capsules, 1 gram, 120-count bottles, Rx only, Manufactured by: S...
Subpotent Drug: Due to oxidation caused by leakage of the contents of the capsules
AQ 120 GFEW, Aquarion Preserved Cartridges (2) 3.7 Gallons each
cGMP deviations.
DAYQUIL COLD & FLU, 32CT/2PK
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
LIQUID NYQUIL a) regular, 12/8oz; b) cherry, 12/8oz
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Bayer 2Pk- 25 CT
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Halls Cough Drops a) BAGS, MENTHOL, 12CT; b) BAGS, HONEY LEM, 12CT; c) BAGS, DEF...
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
TESTO-100 CIII (testosterone 100 mg), 10 Sterile Pellets per carton, Rx only, Ma...
Lack of Assurance of Sterility: Potential microbial contamination of subcutaneous pellets.
Alka Seltzer, a) Original, 2 tablets per packet in 58 count box, UPC: 8155560200...
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
LUCKY ICE, Cool Mouthwash, Alcohol Free, 16.9oz, 12CT, UPC: 808829108989
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Personal Care, Ice Gel, 8oz, 12 count, UPC 048155903463
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.