Recalls / Class III
Class IIID-0166-2020
Product
Ranitidine Tablets USP,150 mg, 8-count bottles, Distributed by: Dolgencorp, LLC, 100 Mission Ridge, Goodlettsville, TN 37073 Made in India NDC 55910-092-79
- Affected lot / code info
- Lot #: NBSB19001DA3, Exp. date 02/2021
Why it was recalled
CGMP DEVIATIONS: One lot of Ranitidine Tablets USP, 150 mg is being recalled because some bottles were empty.
Recalling firm
- Firm
- AuroMedics Pharma LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 279 Princeton Hightstown Rd, East Windsor, New Jersey 08520-1401
Distribution
- Quantity
- 69696 bottles
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2019-09-23
- FDA classified
- 2019-10-29
- Posted by FDA
- 2019-11-06
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0166-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.