Atenolol 25mg bottles mislabeled; contain Clopidogrel 75mg tablets
Golden State Medical Supply Inc. is recalling 2,584 bottles of Atenolol 25mg tablets nationwide. Bottles labeled as Atenolol 25mg actually contain Clopidogrel 75mg tablets—a different medication.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall. Although no illnesses or injuries have been reported, receiving an entirely different medication poses a serious risk to patient safety. FDA Class I classification requires a minimum severity score of 4.
Plain-English summary
Golden State Medical Supply Inc. is recalling 2,584 bottles of Atenolol 25mg tablets (Lot #GS046745, expiration 12/2023) due to a labeling error. Bottles labeled and intended to contain Atenolol 25mg actually contain Clopidogrel 75mg tablets.
Atenolol is a beta-blocker used to treat hypertension and angina. Clopidogrel is an antiplatelet agent used to reduce clot risk. These medications have different therapeutic purposes and different safety profiles. Patients who receive the wrong medication would not receive their intended treatment and could face serious health risks.
The affected product was distributed nationwide. Consumers who have received bottles from lot GS046745 should not take the product and should contact their healthcare provider or pharmacist immediately for guidance. Return the affected bottles to the dispensing pharmacy.
The recalled product
- Product
- ATENOLOL (ATENOLOL)
- Brand
- ATENOLOL
- Manufacturer
- Golden State Medical Supply Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 2,584
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: GS046745
- Exp 12/2023
Distribution
Distributed nationwide across the United States.
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