FDAClass IIJuly 16, 2014

Fluvastatin Capsules USP recall

Fluvastatin Capsules USP, 20 mg, Rx Only, 30-count bottle, manufactured for Teva Pharmaceuticals, Sellersville, PA, by Teva Pharmaceutical IND LTD…

Why was Fluvastatin Capsules USP recalled?

Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling one lot of Fluvastatin Capsules USP, 20 mg due to a customer complaint trend regarding capsule breakage.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: F47008, Exp. 7/2015

Product
Fluvastatin Capsules USP, 20 mg, Rx Only, 30-count bottle, manufactured for Teva Pharmaceuticals, Sellersville, PA, by Teva Pharmaceutical IND LTD…
Recalling firm
Teva Pharmaceuticals USA
Quantity
8,472 Bottles
Distribution
Nationwide and Guam, Puerto Rico, American Samoa, Virgin Islands
Recall date
July 16, 2014
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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