Atenolol Tablets, USP, 25 mg, 1000-count bottle, Rx only, Manufactured by: ALPHAPHARM PTY LTD, Marketed by: GSMS, Incorp
Summary
The FDA issued a Class I for Atenolol Tablets, USP, 25 mg, 1000-count bottle, Rx only, Manufactured by: ALPHA by Golden State Medical Supply Inc.. Reason: Label Mix - up; a bottle labeled as Atenolol 25mg Tablets contained Clopidogrel 75mg Tablets.
Details
Source
Drug Recall
External ID
D-0019-2023
Action Date
2022-11-02
Status
Terminated
Category
drug
Product 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
Lot/Code Info: Lot #: GS046745, Exp 12/2023
Quantity Affected: 2,584 Bottles
Reason for Recall
Label Mix - up; a bottle labeled as Atenolol 25mg Tablets contained Clopidogrel 75mg Tablets
Distribution
USA Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2022-09-29
Company
Camarillo, CA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 39 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Golden State Medical Supply Inc. has 23 FDA actions in our database, including 23 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Golden State Medical Supply Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Golden State Medical Supply Inc. have FDA actions?
Golden State Medical Supply Inc. has 23 FDA actions in our database, including 23 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0019-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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