Drug recalls
627 recallsSTERILE EYE DROPS SOOTHING TEARS (polyethylene glycol 400 0.4% and…
K.C. Pharmaceuticals, Inc
Lack of Assurance of Sterility
Ultra Lubricating Eye Drops (polyethylene 400 0.4%
K.C. Pharmaceuticals, Inc
Lack of Assurance of Sterility
traMADol Hydrochloride Tablets, USP, 50 mg, 500-count bottles
Amneal Pharmaceuticals, LLC
Failed Impurities/Degradation Specifications: N-nitroso-desmethyl-tramadol impurity (NDSRI) was f…
Prazosin Hydrochloride Capsules, USP, 2mg, 100-count bottle, Rx Only
Appco Pharma LLC
cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin im…
Prazosin Hydrochloride Capsules, USP, 5mg, 100-count bottle, Rx Only
Appco Pharma LLC
cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin im…
Bromfenac Ophthalmic Solution 0.07%, 3 ml, Rx only, Sterile
ALEMBIC PHARMACEUTICALS, INC.
Failed Impurities/Degradation Specifications: out of specification at the time of testing i.e.
Prazosin Hydrochloride Capsules, USP, 1mg, 100-count bottle, Rx Only
Appco Pharma LLC
cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin im…
Sterile Eye Drops ORIGINAL FORMULA (tetrahydrozoline HCl 0.05%)
K.C. Pharmaceuticals, Inc
Lack of Assurance of Sterility
Dry Eye Relief Eye Drops, (glycerin 0.2%
K.C. Pharmaceuticals, Inc
Lack of Assurance of Sterility
Sterile EYE DROPS REDNESS LUBRICANT (glycerin 0.25% and naphazoline…
K.C. Pharmaceuticals, Inc
Lack of Assurance of Sterility
EYE DROPS Advanced Relief, (dextran 70 0.1%
K.C. Pharmaceuticals, Inc
Lack of Assurance of Sterility
Sterile EYE DROPS AC (tetrahydrozoline HCl 0.05%, zinc sulfate 0.25%)
K.C. Pharmaceuticals, Inc
Lack of Assurance of Sterility
Meclizine Hydrochloride Tablets, USP 12.5 mg
Amerisource Health Services LLC
Failed tablet specifications.
CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension
Chiesi USA, Inc.
Lack of Assurance of Sterility
Octreotide Acetate for Injectable Suspension
Teva Pharmaceuticals USA, Inc
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food…
Gelatin Capsule Pack for use with the Sodium Iodide I-131 Kit (cont…
Radnostix
Failed Tablet/Capsule Specifications
Octreotide Acetate for Injectable Suspension
Teva Pharmaceuticals USA, Inc
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food…
Levothyroxine Sodium Tablets USP 150 mcg, 1000 Tablets bottle
MACLEODS PHARMA USA, INC
Subpotent Drug
Octreotide Acetate for Injectable Suspension
Teva Pharmaceuticals USA, Inc
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food…
Webcol Alcohol Prep pad (70% isopropyl alcohol) 2 ply
Cardinal Health 200, LLC
Non-Sterility: microbial contamination identified as Paenibacillus phoenicis
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%*
Apotex Corp.
Lack of Assurance of Sterility
Dexamethasone Sodium Phosphate Injection, USP, 100 mg/ 10 mL
SOMERSET THERAPEUTICS LLC
Failed Impurities/Degradation Specifications - OOS impurities result observed during long term st…
Pitavastatin Tablets, 2 mg, packaged in 90-count bottles, Rx only
Annora Pharma Private Limited
Presence of foreign tablets/capsules: one Pitavastatin tablet 1mg found in bottle of Pitavastatin…
Children's Ibuprofen Oral Suspension, USP, 100 mg per 5mL
STRIDES PHARMA INC
Presence of foreign substance: the firm received complaints for a gel-like mass and black particl…
Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only
Zydus Pharmaceuticals (USA) Inc
Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidiz…
Nilotinib Capsules, 150 mg per capsule, packaged in cartons, Rx only
Cipla USA, Inc.
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condit…
Wipes Plus, Hand Sanitizing Alcohol Free BZK Wipes (Benzalkonium Ch…
ACME UNITED CORPORATION
CGMP Deviations
Savannah Antibacterial Towelettes (Benzalkonium Chloride 0.13%)
ACME UNITED CORPORATION
CGMP Deviations
Mojo Max Fusion XXX, 500 mg, one capsule per blister card
Mohamed Hagar
Marketed Without an Approved NDA/ANDA-FDA analysis revealed undeclared sildenafil (13.1 mg/capsul…
MAXIMUM, ZONE 1, 4% Lidocaine Cream, 1/2 oz bottles
HTO Nevada Inc. dba Kirkman
Stability Data Does Not Support Expiry Date.