Apotex Recalls Atorvastatin Calcium Tablets Due to Foreign Tablet Presence
Apotex Inc. is recalling specific bottles of Atorvastatin Calcium 40 mg tablets because a single Pravastatin 40 mg tablet was found inside one bottle.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which indicates a low probability of adverse health consequences. The hazard involves a foreign tablet of a different medication, which is a significant quality issue but does not meet the criteria for higher severity scores without reported injuries.
Plain-English summary
Apotex Inc. is recalling 1,968 bottles of Atorvastatin Calcium Tablets, USP 40 mg. The recall is due to the presence of a foreign tablet, specifically a single Pravastatin 40 mg tablet, found in a bottle of Atorvastatin Calcium 40 mg.
The affected product is identified by Lot RC5439 with an expiration date of 03/2022. The bottles contain 1,000 tablets each and are labeled as Rx Only. The product was distributed in Illinois, Mississippi, New Jersey, Ohio, and Texas.
Consumers who have this specific lot of Atorvastatin Calcium should stop using it and contact their healthcare provider or pharmacist for instructions on how to dispose of the product or obtain a replacement.
The recalled product
- Product
- ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
- Brand
- ATORVASTATIN CALCIUM
- Manufacturer
- Apotex Inc.
- Category
- Drug — Prescription Drug
- Affected units
- 1,968
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 (1)
- Lot: RC5439 Exp. 03/2022
Distribution
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