Recalls / Class II
Class IID-0527-2020
Product
Aurobindo Ranitidine Caspules 150 mg, 60-count bottle, Rx Only Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 NDC 59651-144-60
- Affected lot / code info
- RA1518001-A Jul 2020 RA1518002-A Jul 2020 RA1518005-B Aug 2020 RA1518006-A Aug 2020 RA1519003-A May 2021
Why it was recalled
CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
Recalling firm
- Firm
- AuroMedics Pharma LLC
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 279 Princeton Hightstown Rd, East Windsor, New Jersey 08520-1401
Distribution
- Quantity
- 45,456 bottles
- Distribution pattern
- nationwide
Timeline
- Recall initiated
- 2019-11-06
- FDA classified
- 2019-11-26
- Posted by FDA
- 2019-12-04
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0527-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.