D-1314-2020 Class III Terminated
FDA drug recall D-1314-2020 was initiated by Aurobindo Pharma USA Inc. on May 26, 2020 and is designated Class III. Reason for recall: Failed Impurities/ Degradation Specifications The recall status is terminated (terminated January 10, 2023). Affected quantity: 13322 bottles.
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
- 13322 bottles
Product Description
Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx only, Manufactured for: Prasco Laboratories Mason, OH 45040 USA, Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810, NDC 66993-680-30
Reason for Recall
Failed Impurities/ Degradation Specifications
Distribution Pattern
U.S.A. Nationwide
Code Information
Lot #: 561180046A1, Exp 8/2020