Why it was recalled
CGMP Deviation: Potential cross-contamination with other drug substance during the manufacturing process.
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.
Lot numbers, UPCs & expiration codes
Lot #: GS027852, Expiry: 06/2022.
Where it was sold
Distributed to 1 wholesaler/distributor
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0654-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 2, 2022
- FDA report date
- Mar 23, 2022
- Quantity
- 401 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Golden State Medical Supply Inc.
Original FDA data
Every field from FDA enforcement report D-0654-2022, exactly as published.
Show all FDA fields
- City
- Camarillo
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 89712
- Address
- 5187 Camino Ruiz
- Code information
- Lot #: GS027852, Expiry: 06/2022.
- Postal code
- 93012-8601
- Report date
- Mar 23, 2022
- Product type
- Drugs
- Recall number
- D-0654-2022
- Classification
- Class II
- Recalling firm
- Golden State Medical Supply Inc.
- Product quantity
- 401 bottles
- Termination date
- Sep 13, 2022
- Reason for recall
- CGMP Deviation: Potential cross-contamination with other drug substance during the manufacturing process.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Distributed to 1 wholesaler/distributor
- Recall initiation date
- Mar 2, 2022
- Initial firm notification
- Letter
- Center classification date
- Mar 15, 2022