D-0651-2022 Class II Terminated
FDA drug recall D-0651-2022 was initiated by Direct Rx on Mar 4, 2022 and is designated Class II. Reason for recall: CGMP Deviations: The Recall is due to the potential cross-contamination at the contract manufacturer (Ultra Tab Laboratories Inc.) The recall status is terminated (terminated Dec 2, 2022). Affected quantity: 8 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Mar 16, 2022
- Initiation Date
- Mar 4, 2022
- Termination Date
- Dec 2, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8 bottles
Product Description
Alprazolam C-IV 2 mg, 60-count bottles, Rx Only, Dist. By: Par Pharmaceutical Chestnut Ridge, NY 10977 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC 72189-0058-60
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 #: 07NO1901 Exp. 5/31/22
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0651-2022
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026