D-0227-2022 Class II Terminated
FDA drug recall D-0227-2022 was initiated by Golden State Medical Supply Inc. on Oct 14, 2021 and is designated Class II. 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… The recall status is terminated (terminated Nov 10, 2022). Affected quantity: a) 101 b) 145 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Nov 17, 2021
- Initiation Date
- Oct 14, 2021
- Termination Date
- Nov 10, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- a) 101 b) 145 bottles
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
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
Distribution pattern
Distributed to two distributors located in AZ and MO
Code information
a) Lot: GS038610, Exp: 01/2023; b) GS038891, Exp: 1/2023
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0227-2022
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026