Recalls / Class I
Class ID-0019-2023
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
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
- Brand name
- Atenolol
- Generic name
- Atenolol
- Active ingredient
- Atenolol
- Route
- Oral
- NDCs
- 60429-025, 60429-027, 60429-026
- FDA application
- ANDA073457
- Affected lot / code info
- Lot #: GS046745, Exp 12/2023
Why it was recalled
Label Mix - up; a bottle labeled as Atenolol 25mg Tablets contained Clopidogrel 75mg Tablets
Recalling firm
- Firm
- Golden State Medical Supply Inc.
- Manufacturer
- Golden State Medical Supply, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 5187 Camino Ruiz, N/A, Camarillo, California 93012-8601
Distribution
- Quantity
- 2,584 Bottles
- Distribution pattern
- USA Nationwide
Timeline
- Recall initiated
- 2022-09-29
- FDA classified
- 2022-10-21
- Posted by FDA
- 2022-11-02
- Terminated
- 2025-03-20
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0019-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.