19 recalls · Class I, newest first
Reason Microbial Contamination of Non-Sterile Products: microbial contamination identified as Penicillium brevicompactum observed during routine ongoing…
Reason Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Reason Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Reason Failed Content Uniformity Specifications
Reason Microbial Contamination of Non-Sterile Products: identified as Bacillus cereus.
Reason Presence of Particulate Matter: identified as glass.
Reason Presence of Particulate Matter: identified as glass.
Reason Presence of Particulate Matter: identified as glass.
Reason Microbial contamination of Non-Sterile Products
Reason Presence of Foreign Tablets/Capsules: There is a potential presence of oxycodone HCl tablets, USP 5 mg in bottles.
Reason Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil, an ingredient found in a FDA approved product…
Reason Labeling: Label Mix-Up- Bottles labeled as Digoxin Tablets, USP 0.125 mg contain Digoxin Tablets, USP 0.25mg and bottles labeled as Digoxin Tablets…
Reason Defective container: empty inhaler and leakage observed through the inhaler valve due to partially missing bottom seat (gasket).
Reason Failed Stability Specification and Failed Impurities/Degradation Specifications: out of specification for inactive content ascorbic acid and…
Reason Labeling: Label Mix-up: Unit Dose cartons labeled as Ziprasidone Hydrochloride Capsules, 20 mg were found to contain blister packages labeled as and…
Reason Product mix-up: incorrect product was found inside the G-Supress DX product carton.
Reason Chemical Contamination: FDA testing found Presence of methanol
Reason Chemical Contamination: FDA testing found Presence of methanol
Reason Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared sildenafil and tadalafil, ingredients found in…