Alprazolam Tablets, USP 1mg, 180-count bottles, Rx only, Manufactured by ULTRAlab Laboratories, Inc., NY; Packaged by GSMS, Inc., CA NDC 60429-504-18.
Reported: March 23, 2022 Initiated: March 2, 2022 #D-0654-2022
Product Description
Alprazolam Tablets, USP 1mg, 180-count bottles, Rx only, Manufactured by ULTRAlab Laboratories, Inc., NY; Packaged by GSMS, Inc., CA NDC 60429-504-18.
Reason for Recall
CGMP Deviation: Potential cross-contamination with other drug substance during the manufacturing process.
Details
- Recalling Firm
- Golden State Medical Supply Inc.
- Units Affected
- 401 bottles
- Distribution
- Distributed to 1 wholesaler/distributor
- Location
- Camarillo, CA
Frequently Asked Questions
What product was recalled? ▼
Alprazolam Tablets, USP 1mg, 180-count bottles, Rx only, Manufactured by ULTRAlab Laboratories, Inc., NY; Packaged by GSMS, Inc., CA NDC 60429-504-18.. Recalled by Golden State Medical Supply Inc.. Units affected: 401 bottles.
Why was this product recalled? ▼
CGMP Deviation: Potential cross-contamination with other drug substance during the manufacturing process.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 23, 2022. Severity: Moderate. Recall number: D-0654-2022.
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