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
Reported: March 16, 2022 Initiated: March 4, 2022 #D-0650-2022
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.)
Details
- Recalling Firm
- Direct Rx
- Units Affected
- 16 bottles
- Distribution
- FL, GA, LA
- Location
- Dawsonville, GA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Direct Rx. Units affected: 16 bottles.
Why was this product recalled? ▼
CGMP Deviations: The Recall is due to the potential cross-contamination at the contract manufacturer (Ultra Tab Laboratories Inc.)
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 16, 2022. Severity: Moderate. Recall number: D-0650-2022.
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