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

FDA recall notice · announced December 18, 2019 · Preferred Pharmaceuticals

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

The 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

Reason for recall

CGMP Deviations: Presence of NDMA impurity detected in product.

Notes

Distribution: CA, FL
Lot/code information: Lot #: I2519H, Exp. 12/20; I2719O, Exp. 12/20; J1419O, Exp. 12/20; J2819L, Exp. 12/20
Quantity: 316 bottles
Status: Terminated
Products in this recall event:
- 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 (D-0617-2020)

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