Product Safety Recalls

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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

Mandated?Voluntary: Firm initiated
Recall NumberD-0019-2023
Event ID90909
Generic NameATENOLOL
Active SubstanceATENOLOL
Drug RouteORAL
DistributionUSA Nationwide
Quantity2,584 Bottles
Recall ReasonLabel Mix - up; a bottle labeled as Atenolol 25mg Tablets contained Clopidogrel 75mg Tablets
Drug ClassificationClass I
Drug Code Info20221102
Product NDC60429-025 60429-027 60429-026
Product NUIN0000000161 N0000175556
Pharma Class (EPC)beta-Adrenergic Blocker [EPC]
Recall Initiation Date20220929
Report Date20221102
Classification Date20221021
Address5187 Camino Ruiz
Camarillo, CA 93012-8601
United States
Recalling FirmGolden State Medical Supply Inc.
Initial Notification Letter
Unique Ingredient Identifier50VV3VW0TI
Drug Application NumberANDA073457
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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