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Viatris

24 recalls •

• Categories: Prescription Drugs

Cardura XL (doxazosin) extended release tablets 8 mg, 30-count bottle, Rx only, Distributed by Viatris Specialty LLC, Morgantown, WV 26505, NDC 58151-079-93

Class I - Dangerous

Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.

Dec 23, 2024 Prescription Drugs Nationwide View Details →

Cardura XL (doxazosin) extended release tablets 4 mg, 30 -count bottle, Rx only, Distributed by Viatris Specialty LLC, Morgantown, WV 26505, NDC 58151-078-93

Class I - Dangerous

Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.

Dec 23, 2024 Prescription Drugs Nationwide View Details →

Levothyroxine Sodium Tablets USP, 150 mcg, packaged in a) 90-count bottles (NDC 0378-1815-77) and b) 1000-count bottles (NDC 0378-1815-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

Class I - Dangerous

Superpotent Drug and Subpotent Drug: potency failures obtained

Nov 18, 2024 Prescription Drugs Nationwide View Details →

Levothyroxine Sodium Tablets USP, 100 mcg, packaged in a) 90-count bottles (NDC 0378-1809-77) and b) 1000-count bottles (NDC 0378-1809-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

Class I - Dangerous

Superpotent Drug and Subpotent Drug: potency failures obtained

Nov 18, 2024 Prescription Drugs Nationwide View Details →

Levothyroxine Sodium Tablets USP, 50 mcg, packaged in a) 90-count bottles (NDC 0378-1803-77) and b) 1000-count bottles (NDC 0378-1803-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

Class I - Dangerous

Superpotent Drug and Subpotent Drug: potency failures obtained

Nov 18, 2024 Prescription Drugs Nationwide View Details →

Levothyroxine Sodium Tablets USP, 125 mcg, packaged in a) 90-count bottles (NDC 0378-1813-77) and b) 1000-count bottles (NDC 0378-1813-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

Class I - Dangerous

Superpotent Drug and Subpotent Drug: potency failures obtained

Nov 18, 2024 Prescription Drugs Nationwide View Details →

Levothyroxine Sodium Tablets USP, 200 mcg, packaged in a) 90-count bottles (NDC 0378-1819-77) and b) 1000-count bottles (NDC 0378-1819-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

Class I - Dangerous

Superpotent Drug and Subpotent Drug: potency failures obtained

Nov 18, 2024 Prescription Drugs Nationwide View Details →

Levothyroxine Sodium Tablets USP, 112 mcg, packaged in a) 90-count bottles (NDC 0378-1811-77) and b) 1000-count bottles (NDC 0378-1811-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

Class I - Dangerous

Superpotent Drug and Subpotent Drug: potency failures obtained

Nov 18, 2024 Prescription Drugs Nationwide View Details →

Levothyroxine Sodium Tablets USP, 175 mcg, packaged in a) 90-count bottles (NDC 0378-1817-77) and b) 1000-count bottles (NDC 0378-1817-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

Class I - Dangerous

Superpotent Drug and Subpotent Drug: potency failures obtained

Nov 18, 2024 Prescription Drugs Nationwide View Details →

Levothyroxine Sodium Tablets USP, 137 mcg, packaged in a) 90-count bottles (NDC 0378-1823-77) and b) 1000-count bottles (NDC 0378-1823-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

Class I - Dangerous

Superpotent Drug and Subpotent Drug: potency failures obtained

Nov 18, 2024 Prescription Drugs Nationwide View Details →

Levothyroxine Sodium Tablets USP, 88 mcg, packaged in a) 90-count bottles (NDC 0378-1807-77) and b) 1000-count bottles (NDC 0378-1807-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

Class I - Dangerous

Superpotent Drug and Subpotent Drug: potency failures obtained

Nov 18, 2024 Prescription Drugs Nationwide View Details →

Levothyroxine Sodium Tablets USP, 75 mcg, packaged in a) 90-count bottles (NDC 0378-1805-77) and b) 1000-count bottles (NDC 0378-1805-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

Class I - Dangerous

Superpotent Drug and Subpotent Drug: potency failures obtained

Nov 18, 2024 Prescription Drugs Nationwide View Details →

Levothyroxine Sodium Tablets USP, 25 mcg, packaged in a) 90-count bottles (NDC 0378-1800-77) and b) 1000-count bottles (NDC 0378-1800-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

Class I - Dangerous

Superpotent Drug and Subpotent Drug: potency failures obtained

Nov 18, 2024 Prescription Drugs Nationwide View Details →

Cardura XL (doxazosin) extended release tablets 8mg, 30-count bottles, Rx Only Made in Singapore, Distributed by Roerig Division of Pfizer Inc, NY, NY 10017 NDC 0049-2080-10

Class I - Dangerous

Failed Impurities/Degradation Specifications

Apr 30, 2024 Prescription Drugs Nationwide View Details →

Cardura XL (doxazosin) extended release tablets 4mg, 30-count bottles, Rx Only, Made in Singapore, Distributed by Roerig Division of Pfizer Inc, NY, NY 10017 NDC 0049-2040-10

Class I - Dangerous

Failed Impurities/Degradation Specifications

Apr 30, 2024 Prescription Drugs Nationwide View Details →

Valacyclovir Tablets USP, 500 mg, 90 count bottles, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA, NDC 0378-4275-77

Class I - Dangerous

Failed Tablet/Capsule Specifications: There is a potential for the imprint, M 122, to be missing on some tablets.

Apr 25, 2024 Prescription Drugs Nationwide View Details →

Levsin injection (hyoscyamine sulfate injection, USP), 0.5 mg per ml in water for Injection, 1 ml Ampule (Box of 5 ampules), Rx Only, Distributed by: Meda pharmaceuticals Inc. (a Viatris company) Somerset New Jersey 00873-4120, NDC #0037-9001-05

Class I - Dangerous

CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.

May 25, 2023 Prescription Drugs View Details →

Carvedilol Tablets, USP, 25 mg, 500-count bottles, Rx Only, Mfg: Mylan Pharmaceuticals Inc. Morgantown, WV 36505, Made in India, NDC 0378-3634-05

Class I - Dangerous

Failed Tablet/Capsule Specifications: Tablets exceeds specification for weight and thickness.

Oct 21, 2022 Prescription Drugs Nationwide View Details →

Octreotide Acetate Injection 500 mcg/mL, 10 x 1 mL Single-Dose Unit-of-Use Syringes, For Subcutaneous or Intravenous Use, Rx Only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26505 U.S.A., Made in Italy, NDC: 67457-246-00 (syringe), 67457-246-01 (carton).

Class I - Dangerous

Presence of Particulate Matter: Product complaint for the presence of glass particles in a syringe.

Oct 7, 2022 Prescription Drugs Nationwide View Details →

Ampicillin for Injection, USP, 2 grams/vial NDC 67457-352-02, packaged in 10 x 2 g vials per carton NDC 67457-352-10, Rx only, Mylan Manufactured in India for: Mylan Institutional LLC Rockford, IL 61103 U.S.A

Class I - Dangerous

Presence of Particulate Matter: A complaint was received for the presence of a single strand of hair in one vial.

Sep 21, 2022 Prescription Drugs Nationwide View Details →

Xanax XR (alprazolam) extended-release tablets, 3 mg, 60-count bottle, Rx only, Distributed by Pharmacia & Upjohn Co, Division of Fizer Inc, NY, NY 10017, NDC 0009-0068-07.

Class I - Dangerous

Failed Dissolution Specifications: low out of specification results for dissolution.

Apr 28, 2022 Prescription Drugs Nationwide View Details →

alprazolam XR extended-release tablets, 3 mg, 60-count bottle, Rx only, Distributed by: Greenstone LLC, Peapack, NJ 07977, NDC 59762-0068-1.

Class I - Dangerous

Failed Dissolution Specifications: low out-of-specification dissolution test results observed.

Apr 28, 2022 Prescription Drugs Nationwide View Details →

Lyrica CR (pregabalin) extended release tablets, 330 mg, 30-count bottles, Rx only, Distributed by Parke-Davis Division of Pfizer Inc., NY, NY 10017, NDC 0071-1029-01

Class I - Dangerous

Failed Dissolution Specifications

Aug 23, 2021 Prescription Drugs Nationwide View Details →

Candesartan Cilexetil Tablets, USP 16 mg, 30 count bottles, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 NDC 0378-3231-93

Class I - Dangerous

Failed Impurities/Degradation Specifications; out of specification for Related Compound

Sep 13, 2021 Prescription Drugs Nationwide View Details →