Recalls / Class II
Class IID-0654-2022
Product
Alprazolam Tablets, USP 1mg, 180-count bottles, Rx only, Manufactured by ULTRAlab Laboratories, Inc., NY; Packaged by GSMS, Inc., CA NDC 60429-504-18.
- Affected lot / code info
- Lot #: GS027852, Expiry: 06/2022.
Why it was recalled
CGMP Deviation: Potential cross-contamination with other drug substance during the manufacturing process.
Recalling firm
- Firm
- Golden State Medical Supply Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 5187 Camino Ruiz, N/A, Camarillo, California 93012-8601
Distribution
- Quantity
- 401 bottles
- Distribution pattern
- Distributed to 1 wholesaler/distributor
Timeline
- Recall initiated
- 2022-03-02
- FDA classified
- 2022-03-15
- Posted by FDA
- 2022-03-23
- Terminated
- 2022-09-13
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0654-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.