Pravastatin Tablets Recalled Due to Incorrect Bupropion Filling
International Laboratories is recalling Pravastatin Sodium Tablets 40 mg because they were filled with Bupropion hydrochloride XL Tablets 300 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 mandates a severity score of 5 per the rubric.
Plain-English summary
International Laboratories, Inc. is recalling Pravastatin Sodium Tablets, USP, 40 mg, 30-count bottles. The recall is due to a labeling mix-up where the product labeled as Pravastatin was filled with Bupropion hydrochloride XL Tablets 300 mg.
The affected product is identified by Lot # 115698A and an expiration date of 02/19. The NDC is 54458-925-16. A total of 82,056 bottles were distributed nationwide in the U.S.A. and in Puerto Rico.
Consumers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance on obtaining the correct medication.
The recalled product
- Product
- Pravastatin Sodium Tablets, USP, 40 mg, 30-count bottle, Rx only, Packaged for: International Laboratories, LLC. St. Petersburg, FL 33710, NDC 54458-925-16
- Manufacturer
- International Laboratories, Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 82,056
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 # 115698A
- Exp 02/19
Distribution
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