ATENOLOL Recall D-0019-2023
Description: 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
ATENOLOL Recall D-0019-2023 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | D-0019-2023 |
Event ID | 90909 |
Brand | ATENOLOL |
Generic Name | ATENOLOL |
Manufacturer | ATENOLOL |
Active Substance | ATENOLOL |
Drug Route | ORAL |
Distribution | USA Nationwide |
Quantity | 2,584 Bottles |
Recall Reason | Label Mix - up; a bottle labeled as Atenolol 25mg Tablets contained Clopidogrel 75mg Tablets |
Drug Classification | Class I |
Drug Code Info | 20221102 |
Product NDC | 60429-025 60429-027 60429-026 |
Product NUI | N0000000161 N0000175556 |
Pharma Class (EPC) | beta-Adrenergic Blocker [EPC] |
Recall Initiation Date | 20220929 |
Report Date | 20221102 |
Classification Date | 20221021 |
Address | 5187 Camino Ruiz Camarillo, CA 93012-8601 United States |
Recalling Firm | Golden State Medical Supply Inc. |
Initial Notification | Letter |
Unique Ingredient Identifier | 50VV3VW0TI |
Drug Application Number | ANDA073457 |
Structured Product Labeling (SPL ID) | db8623e0-c2c4-47a9-e053-2995a90a14ef |
Structured Product Labeling (SPL Set ID) | f4f06c00-9024-4e04-a882-0da2b24d8ff7 |
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