September 2022 FDA Recall Atenolol by Golden State Medical Supply Inc.
D-0019-2023 - Label Mix - up; a bottle labeled as Atenolol 25mg Tablets contained Clopidogrel 75mg Tablets

This Class I drug recall was voluntarily initiated by Golden State Medical Supply Inc. on September 29, 2022 for the product Atenolol. The FDA reported the reason for recall as label mix - up; a bottle labeled as atenolol 25mg tablets contained clopidogrel 75mg tablets. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0019-2023

Reason for Recall
Label Mix - up; a bottle labeled as Atenolol 25mg Tablets contained Clopidogrel 75mg Tablets
Initiated
09-29-2022
Reported
11-02-2022
Quantity
2,584 Bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
90909
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
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.
USA Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-20-2025
Product Description About Product Description
Full technical description of the product.
Atenolol Tablets, USP, 25 mg, 1000-count bottle, Rx only, Manufactured by: ALPHAPHARM PTY LTD, Marketed by: GSMS, Incorporated, Camarillo, CA 93012, USA, NDC 60429-027-10

Batch or Lot Expiration Information

Lot# : GS046745, Exp 12/2023

Affected Packages Involved in this Recall

60429-025-90 Atenolol
60429-025-10 Atenolol
60429-026-90 Atenolol
60429-026-10 Atenolol
60429-027-90 Atenolol
60429-027-10 Atenolol