Ranitidine 150 mg tablets, 24 count bottles, NDC 37808-196-01.

FDA recall notice · announced January 15, 2020 · Aaa Pharmaceutical

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

The product

Ranitidine 150 mg tablets, 24 count bottles, NDC 37808-196-01.

Reason for recall

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

Notes

Distribution: Product was distributed to one consignee who may have distributed the product further to their retail stores.
Lot/code information: P134458, Sept 2020 P134943, Aug 2020 P135840, Aug, 2020 P136622, April 2021 P136871, April 2021 P137347, April 2021 P137424, April 2021
Quantity: 34,272 (24-count bottles)
Status: Terminated
Products in this recall event:
- Ranitidine 150 mg tablets, 130 count bottles, NDC 37808-196-04. (D-0646-2020)
- Ranitidine 150 mg tablets, 24 count bottles, NDC 37808-196-01. (D-0645-2020)

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