March 2021 FDA Recall Drug by Golden State Medical Supply Inc.
D-0312-2021 - Failed Impurities/Degradation Specifications

This Class II drug recall was voluntarily initiated by Golden State Medical Supply Inc. on March 19, 2021 for the product Drug. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed in Sold to two wholesalers/distributors under government contract located in PA and TX and the recall is currently terminated.

Recall Number: D-0312-2021

Reason for Recall
Failed Impurities/Degradation Specifications: Out of Specification results obtained for unknown impurities during stability testing by manufacturer
Initiated
03-19-2021
Reported
03-31-2021
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87566
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
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.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Sold to two wholesalers/distributors under government contract located in PA and TX
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-28-2021
Product Description About Product Description
Full technical description of the product.
Omeprazole Delayed Release Capsules, USP, 20 mg, 1000-count bottles, Rx only, Packaged by GSMS Incorporated, Camarillo, CA 93012-8601 USA, NDC 51407-129-10

Batch or Lot Expiration Information

Lot# : GS029673, Exp. Date 5/2021