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Showing 881–900 of 14370 results

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Javygtor Oral Powder (Dr. Reddy's) – Sub-potent Drug (2024)

Sub-potent Drug; powder discoloration associated with decreased potency

FDAApr 8, 2024Nationwide• Dr. Reddy's Laboratories, Inc.

ELV Control Herbal Supplement (World Green Nutrition) – Toxic Ingredient (2024)

FDA Analysis found product labeled as tejocote is actually yellow oleander, which is toxic to humans.

FDAApr 3, 2024DE, OR• World Green Nutrition Inc.

Cyclophosphamide 1g Injection (X-Gen) – Labeling Error (2024)

Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), section 2.3, Preparation, Handling, and Administration. The concentration of the reconstituted product is listed as '20 mg per vial.' This information should read: '20 mg per mL'.

Class IIILow

FDAApr 2, 2024Nationwide• X-Gen Pharmaceuticals Inc.

Cyclophosphamide 500mg Injection (X-Gen) – Labeling Error (2024)

Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), section 2.3, Preparation, Handling, and Administration. The concentration of the reconstituted product is listed as '20 mg per vial.' This information should read: '20 mg per mL'.

FDAApr 2, 2024Nationwide• X-Gen Pharmaceuticals Inc.

Atovaquone Oral Suspension (AvKARE) – Microbial Contamination (2024)

Microbial contamination of a non-sterile product: potential Bacillus cereus contamination.

FDAMar 28, 2024Nationwide• AvKARE

Isotretinoin 40mg Capsules (Teva) – Superpotent Drug (2024)

Superpotent Drug: The 3-month stability result for assay was found to be above specification limit

Class IIModerate

FDAMar 28, 2024Nationwide• Teva Pharmaceuticals USA, Inc

Lansoprazole Capsules (NATCO) – Manufacturing Deviation (2024)

CGMP Deviations

Class IIModerate

FDAMar 27, 2024Nationwide• NATCO Pharma Limited

Nexlizet Tablets (Esperion) – Dissolution Specification (2024)

Failed dissolution specifications: out-of-specification bempedoic acid dissolution at the 0-month timepoint.

FDAMar 27, 2024Nationwide• Esperion

Ipratropium-Albuterol Solution (Cipla) – Short Fill Issue (2024)

Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch.

Class IIModerate

FDAMar 26, 2024Nationwide• Cipla USA, Inc.

Diltiazem Extended-Release Capsules (Glenmark) – Dissolution Failure (2024)

Failed Dissolution Specifications: Out of Specification (OOS) was reported in test of dissolution at the 12th month time point in long term stability study.

Class IIModerate

FDAMar 26, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA

Methylergonovine Tablets (Amneal) – Dissolution Failure (2024)

Failed Dissolution Specifications

Class IIModerate

FDAMar 25, 2024Nationwide• Amneal Pharmaceuticals of New York, LLC

Digoxin Tablets (Novitium Pharma) – Impurity Specification Failure (2024)

Failed Impurities/Degradation Specifications

FDAMar 25, 2024Nationwide• Novitium Pharma LLC

Alcoholada Gel (Aruba Aloe) – Methanol Contamination (2024)

Chemical Contamination: Product manufactured with ethanol API that contains methanol

FDAMar 23, 2024Nationwide• Aruba Aloe Balm N.V.

Lactated Ringer's Injection (B. Braun) – Potential Sterility Leak (2024)

Lack of assurance of sterility: bags have the potential to leak..

Class IIModerate

FDAMar 22, 2024Nationwide• B. Braun Medical Inc

Rifampin Capsules (Lupin) – Subpotent Medication (2024)

Subpotent Drug

Class IIModerate

FDAMar 21, 2024Nationwide• Lupin Pharmaceuticals Inc.

VCF Contraceptive Film (Apothecus) – Manufacturing Deviation (2024)

cGMP Diviations

Class IIModerate

FDAMar 21, 2024Nationwide• Apothecus Pharmaceutical Corp.

Vancomycin Oral Solution (Amneal) – Superpotent Dosage (2024)

Superpotent Drug: Due to overfilling of drug powder

FDAMar 21, 2024Nationwide• Amneal Pharmaceuticals of New York, LLC

Spanish Fly Capsules (Pyramids) – Undeclared Drug Ingredients (2024)

Undeclared Allergen

Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.

FDAMar 19, 2024Nationwide• Pyramids Wholesale Inc.

Libigrow Red Dragon+ (Pyramids) – Undeclared Drug Ingredients (2024)

Undeclared Allergen

Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.

FDAMar 19, 2024Nationwide• Pyramids Wholesale Inc.

Infumorph (Hikma) – expired filter (2024)

The filter included in the carton has an expiration date that has expired prior to the expiration date of the actual product lot.

Class IIModerate

FDAMar 12, 2024Nationwide• Hikma Pharmaceuticals USA Inc.

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