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
Reported: November 17, 2021 Initiated: October 14, 2021 #D-0227-2022
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
Details
- Recalling Firm
- Golden State Medical Supply Inc.
- Units Affected
- a) 101 b) 145 bottles
- Distribution
- Distributed to two distributors located in AZ and MO
- Location
- Camarillo, CA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Golden State Medical Supply Inc.. Units affected: a) 101 b) 145 bottles.
Why was this product 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
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 17, 2021. Severity: Moderate. Recall number: D-0227-2022.
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