Recalls / Class II
Class IID-0319-2020
Product
Rite Aid Pharmacy Maximum Strength Ranitidine Tablets, USP 150 mg-acid reducer Distributed By: Rite Aid 30 Hunter Lane Camp Hill, PA 17011 a) 50 tablets NDC 11822-6052-1; b) 65 tablets NDC 11822-6052-2; c) 95 tablets NDC 11822-4727-3; d) 24 tablets NDC 11822-6051-8
- Affected lot / code info
- All lots remaining within expiry.
Why it was recalled
GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
Recalling firm
- Firm
- Apotex Inc.
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 150 Signet Drive, N/A, North York, N/A N/A, Canada
Distribution
- Quantity
- 215,387 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2019-09-24
- FDA classified
- 2019-11-12
- Posted by FDA
- 2019-11-20
- Status
- Completed
Source: openFDA Drug Enforcement endpoint. Recall record D-0319-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.