Clopidogrel Tablets Recalled Due to Simvastatin Labeling Error
International Laboratories, LLC is recalling Clopidogrel Tablets 75 mg because bottles were found containing Simvastatin Tablets 10 mg.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which is defined as a situation where use of or exposure to the product may cause serious adverse health consequences or death.
Plain-English summary
International Laboratories, LLC is recalling Clopidogrel Tablets, USP 75 mg, 30-count bottles. The recall is due to a labeling mix-up where Simvastatin tablets, USP 10 mg were found in bottles labeled as Clopidogrel tablets, USP 75 mg.
The affected product is identified by Lot # 117099A and an expiration date of 08/19. The NDC number is 54458-888-16. A total of 218,772 bottles were distributed nationwide within the US.
Consumers should check their medication bottles for this specific lot number and expiration date. If the product matches the description, they should stop using it and contact their healthcare provider or pharmacist for guidance on obtaining the correct medication.
The recalled product
- Product
- Clopidogrel Tablets, USP 75 mg, 30-count bottles, Rx only, Packaged for: International Laboratories, LLC St. Petersburg, FL 33710, NDC 54458-888-16
- Manufacturer
- International Laboratories, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 218,772
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 #: 117099A
- Exp. 08/19
Distribution
Distributed nationwide across the United States.
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