Recalls / Class III
Class IIID-1314-2020
Product
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
- Affected lot / code info
- Lot #: 561180046A1, Exp 8/2020
Why it was recalled
Failed Impurities/ Degradation Specifications
Recalling firm
- Firm
- Aurobindo Pharma USA Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 279 Princeton Hightstown Rd, East Windsor, New Jersey 08520-1401
Distribution
- Quantity
- 13322 bottles
- Distribution pattern
- U.S.A. Nationwide
Timeline
- Recall initiated
- 2020-05-26
- FDA classified
- 2020-06-17
- Posted by FDA
- 2020-06-24
- Terminated
- 2023-01-10
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1314-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.