🍔 Food 💊 Drugs 🏥 Medical Devices
HYDROXYPROGESTERONE CAPROATE 250 MG/ML (IN SESAME OIL), Rx Only 4 mL INJECTABLE IM USE. Manufactured by Avella Specialty Pharmacy, Phoenix, AZ 85085. Class II

Reason: Crystallization: Formation of crystals observed in product.

Avella of Deer Valley, Inc. 20141001 Terminated
Distributed: Nationwide
View Details
TOPIRAMATE Tablets 200 mg, 60 Tablet Bottles, Rx Only. Manufactured by Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ USA 08534. NDC 68382-141-14. Class II

Reason: Presence of Foreign Tablets: Presence of topiramate 100 mg tablets comingled with 200 mg tablets.

Zydus Pharmaceuticals USA Inc 20140915 Terminated
Distributed: U.S. Nationwide
View Details
E-Z- GAS II EFFERVESCENT GRANULES Antacid/Antiflatulent ,4 g (0.14 oz), 50 -count box, Rx Only, Manufactured in USA for E-Z EM, Inc. Lake Success, NY 11042 by Tower Laboratories LTD Centerbrook, CT 06409 NDC 10361-793-01 Class III

Reason: Subpotent Drug: Out of Specification (OOS) result during routine stability testing at 24 months.

Bracco Diagnostic Inc 20140918 Terminated
Distributed: Nationwide
View Details
Truvada (200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate) tablets, 30 count bottles, Rx only, Manufactured for Gilead Sciences, Inc. Foster City, CA 94404, NDC 61958-0701-1 Class III

Reason: Presence of Foreign Substance: Truvada was found to contain small red silicone rubber particulates.

Gilead Sciences, Inc. 20140930 Terminated
Distributed: Nationwide
View Details
All sterile products within expiry Class II

Reason: Lack of Sterility Assurance: A recent FDA inspection revealed poor aseptic production practices that result in lack of sterility assurance of products intended to be sterile.

Unique Pharmaceutical, Ltd 20140718 Terminated
Distributed: Nationwide
View Details
N-Acetyl Cysteine 20% 4 mL Vial Stock Code: 4133 Class I

Reason: Non-Sterility: One lot of N-Acetyl Cysteine vials tested positive for Herbaspirillum huttiense.

Unique Pharmaceutical, Ltd 20140718 Terminated
Distributed: Nationwide
View Details
METOCLOPRAMIDE ORAL SOLUTION, USP 5 mg/5 mL, (present as the hydrochloride), 10 mL cups, Rx only. Manufactured by VistaPharm Inc., Largo, FL 33771. NDC 66689-031-01. Class II

Reason: Defective Container: Product leaks when inverted.

VistaPharm, Inc. 20140813 Terminated
Distributed: U.S. Nationwide, including Puerto Rico
View Details
Metoprolol Succinate Extended-release Tablets, USP 50mg, 90-count Bottles, Rx only, Mfg by Mylan Pharmaceuticals, Inc. Morgantown, WV 26505. NDC 0378-4596-77. Class II

Reason: Presence of Foreign Tablets/Capsules: A pharmacist reported a rogue tablet of different size and markings in bottle of Metoprolol

Mylan Pharmaceuticals Inc. 20140703 Terminated
Distributed: Nationwide
View Details
Tarceva (erlotinib) Tablets, 150 mg, 30 count bottle, Rx only, Manufactured by: Kremers Urban Pharmaceuticals Inc. Seymour, IN 47274 NDC 50242-064-01 Class II

Reason: Failed Dissolution Specifications: The product did not meet the acceptance criteria for the dissolution test during the 24 month routine stability testing.

Astellas Pharma US Inc 20140915 Terminated
Distributed: Nationwide
View Details
ZyGenerics ATENOLOL Tablets, USP 25 mg 1000 count bottle, Rx Only Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08634 USA NDC 68382-022-01 Class II

Reason: Superpotent Drug: A complaint was reported by a pharmacist who stated several tablets were noticeably thicker in appearance.

Zydus Pharmaceuticals USA Inc 20140805 Terminated
Distributed: Nationwide
View Details
Page 1,499 of 1,805 | Showing 10 recalls
Data provided by openFDA