PlainRecalls
FDA Drug Moderate Class II Terminated

Fluvastatin Capsules USP, 20 mg, Rx Only, 30-count bottle, manufactured for Teva Pharmaceuticals, Sellersville, PA, by Teva Pharmaceutical IND LTD, Jerusalem, Israel, NDC 0093-7442-56

Reported: July 16, 2014 Initiated: May 29, 2014 #D-1430-2014

Product Description

Fluvastatin Capsules USP, 20 mg, Rx Only, 30-count bottle, manufactured for Teva Pharmaceuticals, Sellersville, PA, by Teva Pharmaceutical IND LTD, Jerusalem, Israel, NDC 0093-7442-56

Reason for Recall

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.

Details

Recalling Firm
Teva Pharmaceuticals USA
Units Affected
8,472 Bottles
Distribution
Nationwide and Guam, Puerto Rico, American Samoa, Virgin Islands
Location
North Wales, PA

Frequently Asked Questions

What product was recalled?
Fluvastatin Capsules USP, 20 mg, Rx Only, 30-count bottle, manufactured for Teva Pharmaceuticals, Sellersville, PA, by Teva Pharmaceutical IND LTD, Jerusalem, Israel, NDC 0093-7442-56. Recalled by Teva Pharmaceuticals USA. Units affected: 8,472 Bottles.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Drug on July 16, 2014. Severity: Moderate. Recall number: D-1430-2014.