Home / Recalls / Aurobindo Pharma USA Inc. / D-1315-2020

D-1315-2020 Class III Terminated

Recalled by Aurobindo Pharma USA Inc. — East Windsor, NJ

Recall Details

Product Type
Drugs
Report Date
June 24, 2020
Initiation Date
May 26, 2020
Termination Date
January 10, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
7547 bottles

Product Description

Olanzapine Tablets, USP 7.5 mg, 30-count bottle, Rx only, Manufactured for: Prasco Laboratories Mason, OH 45040 USA, Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810, NDC 66993-682-30

Reason for Recall

Failed Impurities/ Degradation Specifications

Distribution Pattern

U.S.A. Nationwide

Code Information

Lot #: 563180012A1, Exp 8/2020

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  • D-0077-2025 Class II — Cinacalcet Tablets, 30 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-831-3 (November 7, 2024)
  • D-0079-2025 Class II — Cinacalcet Tablets, 90 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-833-3 (November 7, 2024)
  • D-0641-2024 Class I — Healthy Living Acetaminophen, Aspirin (NSAID) and Caffeine, tablets USP, 250 mg/ (July 11, 2024)
  • D-0491-2024 Class II — Clorazepate Dipotassium Tablets, USP, 3.75 mg, a) 100 tablets per bottle, NDC 13 (April 24, 2024)
  • D-0492-2024 Class II — Clorazepate Dipotassium Tablets, USP, 7.5 mg, a) 100 tablets per bottle, NDC 131 (April 24, 2024)
  • D-1171-2023 Class II — Rasagiline Tablets 0.5mg, 30-count bottle, Rx only, Mylan Pharmaceuticals Inc. M (August 2, 2023)
  • D-1087-2023 Class II — Rufinamide Tablets, USP 200 mg, packaged in 120-count bottle, Rx only, Distribut (July 21, 2023)