Ranitidine Tablets, USP, 150 mg, 100 Tablets (10 tablets x 10 blister card), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC carton: 60687-322-01; NDC Unit Dose Card: 60687-322-11

FDA recall notice · announced March 18, 2020 · American Health Packaging

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

The product

Ranitidine Tablets, USP, 150 mg, 100 Tablets (10 tablets x 10 blister card), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC carton: 60687-322-01; NDC Unit Dose Card: 60687-322-11

Reason for recall

CGMP Deviations: Potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.

Notes

Distribution: Nationwide USA
Lot/code information: Lot, expiry: Lots 179516, 179745, exp 12/31/2019; Lot 180712, exp 02/29/2020; Lot 180819, exp 04/30/2020; Lots 181403, 182544, 183155, 183236, exp 05/31/2020; Lots 185739, 186600, 186702, exp 12/31/2020
Quantity: 53,619 cartons
Status: Terminated
Products in this recall event:
- Ranitidine Tablets, USP, 150 mg, 100 Tablets (10 tablets x 10 blister card), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC carton: 60687-322-01; NDC Unit D (D-1003-2020)

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