Why it was recalled
Failed Impurities/Degradation Specifications: Out of Specification results obtained for unknown impurities during stability testing by manufacturer
Product description
Omeprazole Delayed Release Capsules, USP, 20 mg, 1000-count bottles, Rx only, Packaged by GSMS Incorporated, Camarillo, CA 93012-8601 USA, NDC 51407-129-10
Lot numbers, UPCs & expiration codes
Lot #: GS029673, Exp. Date 5/2021
Where it was sold
Sold to two wholesalers/distributors under government contract located in PA and TX
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-0312-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 19, 2021
- FDA report date
- Mar 31, 2021
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Golden State Medical Supply Inc.
Original FDA data
Every field from FDA enforcement report D-0312-2021, exactly as published.
Show all FDA fields
- City
- Camarillo
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 87566
- Address
- 5187 Camino Ruiz
- Code information
- Lot #: GS029673, Exp. Date 5/2021
- Postal code
- 93012-8601
- Report date
- Mar 31, 2021
- Product type
- Drugs
- Recall number
- D-0312-2021
- Classification
- Class II
- Recalling firm
- Golden State Medical Supply Inc.
- Termination date
- Jul 28, 2021
- Reason for recall
- Failed Impurities/Degradation Specifications: Out of Specification results obtained for unknown impurities during stability testing by manufacturer
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Omeprazole Delayed Release Capsules, USP, 20 mg, 1000-count bottles, Rx only, Packaged by GSMS Incorporated, Camarillo, CA 93012-8601 USA, NDC 51407-129-10
- Distribution pattern
- Sold to two wholesalers/distributors under government contract located in PA and TX
- Recall initiation date
- Mar 19, 2021
- Initial firm notification
- Letter
- Center classification date
- Mar 24, 2021