Drug product
Alprazolam C-IV 1 mg 60-count bottles, Rx Only, Dist. By: Par Pharmaceutical Chestnut Ridge, NY 10977 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC 61919-836-60
D-0650-2022
Product summary
- Firm
- Direct Rx
- Event
- Event 89749
- Status
- Terminated
- Classification
- Class II
- Quantity
- 16 bottles
- Official record key
drug-enforcement:D-0650-2022
Official wording
Reason: CGMP Deviations: The Recall is due to the potential cross-contamination at the contract manufacturer (Ultra Tab Laboratories Inc.)
Code information: Lot #: 19AU1910 Exp. 5/31/22
Distribution pattern: FL, GA, LA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations