Drug product
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
D-1430-2014
Product summary
- Event
- Event 68441
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8,472 Bottles
- Official record key
drug-enforcement:D-1430-2014
Official wording
Reason: 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.
Code information: Lot #: F47008, Exp. 7/2015
Distribution pattern: Nationwide and Guam, Puerto Rico, American Samoa, Virgin Islands
Derived failure modes
-
Unknown
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.