Drug 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
D-1003-2020
Product summary
- Event
- Event 85070
- Status
- Terminated
- Classification
- Class II
- Quantity
- 53,619 cartons
- Official record key
drug-enforcement:D-1003-2020
Official wording
Reason: CGMP Deviations: Potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.
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
Distribution pattern: Nationwide USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations