Class II · Moderate risk
fentaNYL (as citrate)
Lack of assurance of sterility: Product bags leaking at seam.
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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
Class II · Moderate risk
Blephamide
Failed Impurities/Degradation Specifications: stability testing results did not meet the specification for impurities.
Class II · Moderate risk
Buprenorphine HCI Injection
Crystallization: due to the presence of white, crystalline particulates, adhered to the side and bottom of the glass vials, which are comprised of principally dextrose and the buprenorphine active component.
Class III · Low risk
Minivelle (estradiol Transdermal System)
Defective Delivery System: Out of specification for peel force from the release liner specification during stability testing at 18M 25C/60%RH.
Class III · Low risk
Acyclovir Tablets
Presence of Foreign Substance: human hair melded into tablet.
Class III · Low risk
Amoxicillin and Clavulanate Potassium Tablets
Subpotent Drug; Clavulanic Acid