D-0650-2022 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- March 16, 2022
- Initiation Date
- March 4, 2022
- Termination Date
- December 2, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 16 bottles
Product Description
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
Reason for Recall
CGMP Deviations: The Recall is due to the potential cross-contamination at the contract manufacturer (Ultra Tab Laboratories Inc.)
Distribution Pattern
FL, GA, LA
Code Information
Lot #: 19AU1910 Exp. 5/31/22