cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
All Recalls
95,025 total recalls in our database
Phenylephrine HCl Injection 40 mg per 250 mL in 0.9% Sodium Chloride, 40 mg, 250 mL excel bag, Rx only, Athenex Pharma Solutions, LLC, Clarence, NY, 14031, NDC 76154-493-15
Athenex Pharma Solutions
Defective container
CGMP Deviations: FDA analysis found product to contain acetal and acetaldehyde above specification limits.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Presence of particulate matter: particulates composed of carbon and oxygen with varying amounts of iron and trace amounts of sodium, silicon, chromium, aluminum and cellulose.
Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL (60 grams) bottle, Rx only, Teligent Pharma, Inc., Buena, New Jersey 08310, NDC 52565-010-59.
Teligent Pharma
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Microbial Contamination of Non-sterile Product; FDA analysis found the product to be contaminated with Bacillus cereus.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Hydrocortisone Butyrate Lotion 0.1%, 4 fl. oz. (118 mL) bottle, Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-159-04.
Teligent Pharma
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Super Potent and Failed Reconstitution Time
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Super Potent
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.