Ranitidine 300 mg, 30 Tabs bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 61919-455-30

FDA recall notice · announced October 14, 2020 · Direct Rx

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

The product

Ranitidine 300 mg, 30 Tabs bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 61919-455-30

Reason for recall

CGMP Deviations: Presence of NDMA impurity detected in product.

Notes

Distribution: FL, GA
Lot/code information: Lot: 29JA1915 Exp. 09/30/2021
Quantity: 26 bottles
Status: Terminated
Products in this recall event:
- Ranitidine 150 mg, a) 60 Tabs (NDC 61919-339-60); and b) 90 Tabs (NDC 61919-339-90) bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 (D-0016-2021)
- Ranitidine 300 mg, 30 Tabs bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 61919-455-30 (D-0017-2021)

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