Class II · Moderate risk
PHENYLephrine HCL in 0.9% Sodium Chloride injectable
Lack of assurance of sterility: Product bags leaking at seam.
FDA Drug Recalls
1,134 recalls, newest first
Class II · Moderate risk
MAGNESIUM Sulfate added to 100 mL 0.9% Sodium Chloride injectable
Lack of assurance of sterility: Product bags leaking at seam.
Class II · Moderate risk
ceFAZolin sodium added to 100 mL 0.9% Sodium Chloride injectable
Lack of assurance of sterility: Product bags leaking at seam.
Class II · Moderate risk
ceFAZolin sodium added to 100 mL 0.9% Sodium Chloride injectable
Lack of assurance of sterility: Product bags leaking at seam.
Class II · Moderate risk
HYDROmorphone HCL in 0.9% Sodium Chloride injectable
Lack of assurance of sterility: Product bags leaking at seam.
Class II · Moderate risk
fentaNYL (as citrate)
Lack of assurance of sterility: Product bags leaking at seam.
Class II · Moderate risk
fentaNYL (as citrate)
Lack of assurance of sterility: Product bags leaking at seam.
Class II · Moderate risk
fentaNYL (as citrate)
Lack of assurance of sterility: Product bags leaking at seam.
Class II · Moderate risk
morphine sulfate in 0.9% Sodium Chloride injectable
Lack of assurance of sterility: Product bags leaking at seam.
Class II · Moderate risk
morphine sulfate in 0.9% Sodium Chloride injectable
Lack of assurance of sterility: Product bags leaking at seam.
Class II · Moderate risk
Nystatin Topical Powder
Presence of Foreign Substance: potential presence of plastic particles.
Class III · Low risk
Nystatin Oral Suspension
Failed Impurities/Degradation Specifications: Presence of an impurity peak that exceeds approved specification.
Class I · High risk
Mibelas 24 Fe
Contraceptive Tablets Out of Sequence- First 4 pills of the packet are brown, instead of the last four pills and the expiry/lot was not printed on the package.
Class II · Moderate risk
Milrinone Lactate in 5% Dextrose Injection
Lack of assurance of sterility: customer complaints received for the presence of leaks.
Class II · Moderate risk
Fluconazole Injection
Lack of assurance of sterility: customer complaints received for the presence of leaks.
Class II · Moderate risk
Oxygen Refrigerated Liquid USP UN 1073
GMP Deviations: The firm does not include an SOP for testing for out of specifications.
Class II · Moderate risk
Divalproex Sodium Delayed Release Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Divalproex Sodium Delayed Release Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Divalproex Sodium Delayed Release Tablets
Failed Dissolution Specifications
Class III · Low risk
Montelukast Sodium Oral Granules
Failed Impurities/Degradation Specifications; out of specification results for Sulphoxide Impurity and Total Impurities
Class III · Low risk
Benzonatate capsules
Failed Stability Specifications: Out of Specification results obtained for preservative Methylparaben content.
Class III · Low risk
Hydrocortisone Lotion
Superpotent Drug: above specification for the assay.
Class III · Low risk
Amlodipine Besylate Tablet
PRESENCE OF FOREIGN TABLETS/CAPSULES: A 2.5 mg Amlodipine Besylate tablet was found co-mingled with 10 mg Amlodipine Besylate tablets in a bottle labeled as Amlodipine Besylate 10 mg.
Class I · High risk
GEC LX Laxoplex 60 capsules Dietary Supplement
Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplement: FDA analysis found the product to tainted with undeclared anabolic steroids and steroid like substances.
Class III · Low risk
Famotidine for Oral Suspension USP
CGMP Deviations