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
Check against the official notice below — it lists the full affected range.
Golden State Medical Supply Inc. is recalling Ezetimibe and Simvastatin Tablets (10 mg/40 mg) in two package sizes—90 tablets and 500 tablets—manufactured by Dr. Reddy's Laboratories LA LLC. The recall was initiated because the product was manufactured using an excipient that failed conductivity specifications, and some bottles were found to contain incorrect Ezetimibe and Simvastatin Tablets (10 mg/10 mg) instead of the correct formulation. The affected lots are GS038610 and GS038891, both expiring in January 2023, totaling 101 bottles of the 90-tablet size and 145 bottles of the 500-tablet size that were distributed to two distributors in Arizona and Missouri.
The source document does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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
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: Distributed to two distributors located in AZ and MO Quantity: a) 101 b) 145 bottles Lot/code info: a) Lot: GS038610, Exp: 01/2023; b) GS038891, Exp: 1/2023
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.