Recalls / Class II
Class IID-0797-2020
Product
Preferred Pharmaceuticals, Inc, Ranitidine Tablets, 300 mg, Rx Only, a) 14 count bottles (NDC: 68788-6382-1), b) 30 count bottles (NDC: 68788-6382-3), c) 90 count bottles (NDC: 68788-6382-9), d) 100 count bottles (NDC: 68788-6382-0)
- Affected lot / code info
- Lot #: All lots within expiry
Why it was recalled
CGMP Deviations: Presence of NDMA impurity detected in product.
Recalling firm
- Firm
- Preferred Pharmaceuticals, Inc
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 1250 N Lakeview Ave Ste O, Anaheim, California 92807-1801
Distribution
- Quantity
- 39,172 tablets
- Distribution pattern
- Distribution to physicians in the following states: AL, AZ, CA, FL, GA, IN, and SC
Timeline
- Recall initiated
- 2020-01-07
- FDA classified
- 2020-01-20
- Posted by FDA
- 2020-01-29
- Terminated
- 2023-12-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0797-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.