D-0797-2020 Class II Terminated
FDA drug recall D-0797-2020 was initiated by Preferred Pharmaceuticals, Inc on January 7, 2020 and is designated Class II. Reason for recall: CGMP Deviations: Presence of NDMA impurity detected in product. The recall status is terminated (terminated December 14, 2023). Affected quantity: 39,172 tablets.
Recall Details
- Product Type
- Drugs
- Report Date
- January 29, 2020
- Initiation Date
- January 7, 2020
- Termination Date
- December 14, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 39,172 tablets
Product Description
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)
Reason for Recall
CGMP Deviations: Presence of NDMA impurity detected in product.
Distribution Pattern
Distribution to physicians in the following states: AL, AZ, CA, FL, GA, IN, and SC
Code Information
Lot #: All lots within expiry