Multi-event October 2021 FDA Recall Ezetimibe And Simvastatin by Golden State Medical Supply Inc.
This Multi-event Class II drug recall was voluntarily initiated by Golden State Medical Supply Inc. on October 14, 2021 for the product Ezetimibe And Simvastatin. The FDA reported the reason for recall as 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. The product was distributed in Distributed to two distributors located in AZ and MO and the recall is currently terminated.
Reported Recall Events
Recall Number: D-0227-2022
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
10-14-2021
11-17-2021
a) 101 b) 145 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Golden State Medical Supply Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Distributed to two distributors located in AZ and MO
11-10-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
Batch or Lot Expiration Information
Lot# a) Lot: GS038610, Exp: 01/2023; b) GS038891, Exp: 1/2023
Affected Packages Involved in this Recall
Recall Number: D-0228-2022
Failed Excipient Specification; product manufactured using an excipient found to be OOS for conductivity
10-14-2021
11-17-2021
49
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Golden State Medical Supply Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Distributed to two distributors located in AZ and MO
11-10-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Ezetimibe and Simvastatin Tablets, 10 mg/80mg, 500 tablet bottles, Rx only, Manufactured by Dr. Reddy's Laboratories LA LLC Shreveport, LA 71106 USA, Packaged by GSMS, Incorporated Camarillo, CA 93012 USA; NDC 51407-193-05
Batch or Lot Expiration Information
Lot# GS040048, Exp: 1/2023
