Drug product
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
Product summary
- Firm
- Direct Rx
- Event
- Event 86498
- Status
- Terminated
- Classification
- Class II
- Quantity
- a) 54 bottles; b) 26 bottles
- Official record key
drug-enforcement:D-0016-2021
Official wording
Reason: CGMP Deviations: Presence of NDMA impurity detected in product.
Code information: Lots: a) 09AU1911 Exp. 02/28/2022; b) 09SE1904 Exp. 03/31/2022
Distribution pattern: FL, GA
Derived failure modes
-
Foreign material or chemical contamination
NDMA impurity
-
Manufacturing or process control
CGMP Deviations