FDA Recall D-0019-2023
Golden State Medical Supply Inc. · Camarillo, CA
Class I — life-threatening Terminated 903 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence 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
Reason for recall
Label Mix - up; a bottle labeled as Atenolol 25mg Tablets contained Clopidogrel 75mg Tablets
Recall record
- Recall number
D-0019-2023- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- USA Nationwide
- Recall initiated
- 2022-09-29
- Classified by FDA Center
- 2022-10-21
- FDA published
- 2022-11-02
- Terminated
- 2025-03-20
- Recalling firm
- Golden State Medical Supply Inc.
- Firm location
- Camarillo, CA
Drug identification
- Brand name(s)
- ATENOLOL
- Generic name(s)
- ATENOLOL
- Manufacturer(s)
- Golden State Medical Supply, Inc.
- NDC(s)
60429-025, 60429-026, 60429-027- Route(s)
- ORAL