Why it was recalled
Failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured using an excipient found to be OOS for conductivity and some Ezetimibe and Simvastatin Tablets, 10 mg/10 mg were found in the bottle
Product description
Ezetimibe and Simvastatin Tablets, 10 mg/40mg, a) 90 Tablets, b) 500 tablets, Rx only, Manufactured by Dr. Reddy's Laboratories LA LLC Shreveport, LA 71106 USA, Packaged by GSMS, Incorporated Camarillo, CA 93012 USA; NDC: a) 51407-192-90, b) 51407-192-05
Lot numbers, UPCs & expiration codes
a) Lot: GS038610, Exp: 01/2023; b) GS038891, Exp: 1/2023
Where it was sold
Distributed to two distributors located in AZ and MO
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-0227-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 14, 2021
- FDA report date
- Nov 17, 2021
- Quantity
- a) 101 b) 145 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Golden State Medical Supply Inc.
Original FDA data
Every field from FDA enforcement report D-0227-2022, exactly as published.
Show all FDA fields
- City
- Camarillo
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 88866
- Address
- 5187 Camino Ruiz
- Code information
- a) Lot: GS038610, Exp: 01/2023; b) GS038891, Exp: 1/2023
- Postal code
- 93012-8601
- Report date
- Nov 17, 2021
- Product type
- Drugs
- Recall number
- D-0227-2022
- Classification
- Class II
- Recalling firm
- Golden State Medical Supply Inc.
- Product quantity
- a) 101 b) 145 bottles
- Termination date
- Nov 10, 2022
- Reason for recall
- Failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured using an excipient found to be OOS for conductivity and some Ezetimibe and Simvastatin Tablets, 10 mg/10 mg were found in the bottle
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Ezetimibe and Simvastatin Tablets, 10 mg/40mg, a) 90 Tablets, b) 500 tablets, Rx only, Manufactured by Dr. Reddy's Laboratories LA LLC Shreveport, LA 71106 USA, Packaged by GSMS, Incorporated Camarillo, CA 93012 USA; NDC: a) 51407-192-90, b) 51407-192-05
- Distribution pattern
- Distributed to two distributors located in AZ and MO
- Recall initiation date
- Oct 14, 2021
- Initial firm notification
- Letter
- Center classification date
- Nov 9, 2021