Class II · Moderate risk
Metformin Hydrochloride Extended- Release 500mg
Presence of Foreign Tablets/Capsules.
FDA Drug Recalls
621 recalls · Class II, newest first
Class II · Moderate risk
Clobazam Tablets
Presence of Foreign Tablets/Capsules
Class II · Moderate risk
Metformin Hydrochloride Extended-Release Tablets
Presence of Foreign Tablets/Capsules: A Paracetamol 500 mg tablet was found in a 1000-count bottle of Metformin HCL ER Tablets USP, 500 mg.
Class II · Moderate risk
Progesterone Injection USP
Presence of Particulate Matter: A market complaint was received of a glass piece in the vial.
Class II · Moderate risk
Clobazam Tablets
Presence of Foreign Tablets/Capsules
Class II · Moderate risk
Lisinopril Tablets
Presence of Foreign Object: A pharmacist discovered a metal fragment embedded in a lisinopril 10 mg tablet.
Class II · Moderate risk
Venofer (iron sucrose)
Presence of Particulate Matter: Potential for glass delamination from the vials.
Class II · Moderate risk
Venofer (iron sucrose)
Presence of Particulate Matter: Potential for glass delamination from the vials.
Class II · Moderate risk
Venofer (iron sucrose)
Presence of Particulate Matter: Potential for glass delamination from the vials.
Class II · Moderate risk
Atorvastatin Calcium Tablets
Presence of Foreign Tablets/Capsules: A Carbamazepine Extended-Release 400 mg tablet was found in a 1000-count bottle of Atorvastatin Calcium Tablets, USP 40 mg.
Class II · Moderate risk
Gabapentin Tablets
Presence of Foreign Tablets; 3 fused tablets of Metformin ER 500 mg were found in bottle of Gabapentin Tablets
Class II · Moderate risk
Progesterone Injection
Presence of Particulate Matter: Complaint received of a glass particle in the vial.
Class II · Moderate risk
Cyanocobalamin Injection
Presence of particulate matter: glass
Class II · Moderate risk
Budesonide
CGMP Deviations and Presence of Particulate Matter: Glass
Class II · Moderate risk
Allopurinol Tablets
Presence of foreign substance.
Class II · Moderate risk
Losartan Potassium and Hydrochlorothiazide Tablets
Presence of foreign substance: plastic-like substance.
Class II · Moderate risk
Metoprolol Tartrate Tablets USP
Presence of Foreign Substance: metal in tablet
Class II · Moderate risk
TraMADol HCl 50 mg Tablet
Presence of Foreign Tablets: Manufacturer received a report from a Pharmacist who reported finding a tablet of baclofen in a bottle of 1000-count tramadol
Class II · Moderate risk
traMADol Hydrochloride Tablets
Presence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count tramadol
Class II · Moderate risk
MethylPREDNISolone Acetate Injectable Suspension
Presence of Particulate Matter: Potential for black particulates in the drug product.
Class II · Moderate risk
Progesterone 200 mg
Presence of Foreign Substance; Broken metal piece found embedded in tablet.
Class II · Moderate risk
Haloperidol decanoate Injection 50mg/mL
Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI).
Class II · Moderate risk
Cefdinir for Oral Suspension USP 125 mg/5 mL
Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.
Class II · Moderate risk
Cefdinir for Oral Suspension USP 250 mg/5 mL
Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.
Class II · Moderate risk
Lidocaine HCL 1%
Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.