D-0654-2022 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- March 23, 2022
- Initiation Date
- March 2, 2022
- Termination Date
- September 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.