Teva Recalls Fluvastatin Capsules Due to Reported Capsule Breakage
Teva Pharmaceuticals is voluntarily recalling one lot of Fluvastatin Capsules USP, 20 mg, due to a customer complaint trend regarding capsule breakage.
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 II and is a voluntary precautionary recall based on a complaint trend regarding physical integrity (capsule breakage) rather than a confirmed high-risk contamination or reported injury.
Plain-English summary
Teva Pharmaceuticals USA, Inc. is voluntarily recalling one lot of Fluvastatin Capsules USP, 20 mg. The recall is being conducted due to a customer complaint trend regarding capsule breakage.
The affected product is Fluvastatin Capsules USP, 20 mg, Rx Only, 30-count bottles. The specific lot number is F47008, with an expiration date of 7/2015. The NDC for the product is 0093-7442-56. The product was manufactured for Teva Pharmaceuticals in Sellersville, PA, by Teva Pharmaceutical IND LTD in Jerusalem, Israel.
A total of 8,472 bottles were distributed nationwide and in Guam, Puerto Rico, American Samoa, and the Virgin Islands. Consumers should check their medication for this specific lot number and expiration date. If the product matches the recalled lot, they should stop using it and contact their healthcare provider or pharmacist for guidance.
The recalled product
- Product
- FLUVASTATIN (FLUVASTATIN)
- Brand
- FLUVASTATIN
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 8,472
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 #: F47008
- Exp. 7/2015
UPCs (2)
- 0300937443568
- 0300937442561
Distribution
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