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)

FDA recall notice · announced January 29, 2020 · Preferred Pharmaceuticals

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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)

Reason for recall

CGMP Deviations: Presence of NDMA impurity detected in product.

Notes

Distribution: Distribution to physicians in the following states: AL, AZ, CA, FL, GA, IN, and SC
Lot/code information: Lot #: All lots within expiry
Quantity: 39,172 tablets
Status: Terminated
Products in this recall event:
- Preferred Pharmaceuticals, Inc, Ranitidine Tablets, 150 mg, a) 30 count bottles (NDC: 68788-7388-3), b) 60 count bottles (NDC: 68788-7388-6), c) 90 count bottles (NDC: 68788-7388-9), d) 100 count bott (D-0796-2020)
- 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 c (D-0797-2020)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.