Recalls / Class II
Class IID-0526-2020
Product
DG Health Acid Reducer Ranitidine Tablets 150 mg, 8-count carton, Distributed by: Dolgencorp LLC 100 Mission Ridge Goodletville TN 37072 NDC 55910-092-79
- Affected lot / code info
- Lot # NBSB19001DA3; Exp FEB 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
- 69,696 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-0526-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.