Recalls / Class II
Class IID-0617-2020
Product
Ranitidine Tablets, USP 150 mg, OTC, a.) 30 count bottle (NDC 68788-7078-03), b.) 60 count bottle (NDC 68788-7078-06), Mfg: Amneal Pharmaceuticals
- Affected lot / code info
- Lot #: I2519H, Exp. 12/20; I2719O, Exp. 12/20; J1419O, Exp. 12/20; J2819L, Exp. 12/20
Why it was recalled
CGMP Deviations: Presence of NDMA impurity detected in product.
Recalling firm
- Firm
- Preferred Pharmaceuticals, Inc
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 1250 N Lakeview Ave Ste O, N/A, Anaheim, California 92807-1801
Distribution
- Quantity
- 316 bottles
- Distribution pattern
- CA, FL
Timeline
- Recall initiated
- 2019-12-02
- FDA classified
- 2019-12-09
- Posted by FDA
- 2019-12-18
- Terminated
- 2023-05-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0617-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.