Drugs & Medicine Recalls
Pharmaceutical recall notices, chemical impurities, and biological contamination.
Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%, povidone 0...
Lack of Assurance of Sterility
Prazosin Hydrochloride Capsules, USP, 5mg, 100-count bottle, Rx Only, Manufactur...
cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
Bromfenac Ophthalmic Solution 0.07%, 3 ml, Rx only, Sterile, Manufactured for: A...
Failed Impurities/Degradation Specifications: out of specification at the time of testing i.e. 20th month stability testing.
Prazosin Hydrochloride Capsules, USP, 2mg, 100-count bottle, Rx Only, Manufactu...
cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
Ultra Lubricating Eye Drops (polyethylene 400 0.4%, propylene glycol 0.3%), Ster...
Lack of Assurance of Sterility
Dry Eye Relief Eye Drops, (glycerin 0.2%, hypromellose 0.2% and polyethylene gly...
Lack of Assurance of Sterility
Sterile EYE DROPS REDNESS LUBRICANT (glycerin 0.25% and naphazoline HCl 0.012%),...
Lack of Assurance of Sterility
EYE DROPS Advanced Relief, (dextran 70 0.1%, polyethylene glycol 400 1% and tetr...
Lack of Assurance of Sterility
Sterile Eye Drops ORIGINAL FORMULA (tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15mL...
Lack of Assurance of Sterility
traMADol Hydrochloride Tablets, USP, 50 mg, 500-count bottles, Rx only, Manufac...
Failed Impurities/Degradation Specifications: N-nitroso-desmethyl-tramadol impurity (NDSRI) was found out of the specification at 24-month stability interval during Long term stability (25¿C/60%RH).
STERILE EYE DROPS SOOTHING TEARS (polyethylene glycol 400 0.4% and propylene gly...
Lack of Assurance of Sterility
Prazosin Hydrochloride Capsules, USP, 1mg, 100-count bottle, Rx Only, Manufactur...
cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
Magnesium Sulfate in Water for Injection, 4g/100 mL (40mg/mL) IV bag, further pa...
Product mix up: a foil pouch labeled "Magnesium Sulfate in Water for Injection, 4 g/100 mL" actually contained an IV bag of Tranexamic Acid instead.
Sterile EYE DROPS AC (tetrahydrozoline HCl 0.05%, zinc sulfate 0.25%), 0.5 fl. o...
Lack of Assurance of Sterility
Meclizine Hydrochloride Tablets, USP 12.5 mg, (a) 50 Tablets [5 x 10] (NDC 60687...
Failed tablet specifications.
Levothyroxine Sodium Tablets USP 150 mcg, 1000 Tablets bottle, Rx Only, Manufact...
Subpotent Drug
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 20 ...
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 10 ...
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-Vial...
Lack of Assurance of Sterility
Gelatin Capsule Pack for use with the Sodium Iodide I-131 Kit (containing 5 empt...
Failed Tablet/Capsule Specifications
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 ...
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%*, 5 mL, Rx On...
Lack of Assurance of Sterility
Children's Ibuprofen Oral Suspension, USP, 100 mg per 5mL, 4 FL OZ (120 mL) bott...
Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product.
Webcol Alcohol Prep pad (70% isopropyl alcohol) 2 ply, 200 count boxes, Cardinal...
Non-Sterility: microbial contamination identified as Paenibacillus phoenicis