D-0654-2022 Class II Terminated
FDA drug recall D-0654-2022 was initiated by Golden State Medical Supply Inc. on Mar 2, 2022 and is designated Class II. Reason for recall: CGMP Deviation: Potential cross-contamination with other drug substance during the manufacturing process. The recall status is terminated (terminated Sep 13, 2022). Affected quantity: 401 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Mar 23, 2022
- Initiation Date
- Mar 2, 2022
- Termination Date
- Sep 13, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 401 bottles
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.
Distribution Pattern
Distributed to 1 wholesaler/distributor
Code Information
Lot #: GS027852, Expiry: 06/2022.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0654-2022
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026