PlainRecalls
FDA Drug Moderate Class II Terminated

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

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.