Recalls / Class II
Class IID-1430-2014
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
- Brand name
- Fluvastatin
- Generic name
- Fluvastatin
- Active ingredient
- Fluvastatin Sodium
- Route
- Oral
- NDCs
- 0093-7442, 0093-7443
- FDA application
- ANDA078407
- Affected lot / code info
- Lot #: F47008, Exp. 7/2015
Why it was 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.
Recalling firm
- Firm
- Teva Pharmaceuticals USA
- Manufacturer
- Teva Pharmaceuticals USA, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1090 Horsham Rd, North Wales, Pennsylvania 19454-1505
Distribution
- Quantity
- 8,472 Bottles
- Distribution pattern
- Nationwide and Guam, Puerto Rico, American Samoa, Virgin Islands
Timeline
- Recall initiated
- 2014-05-29
- FDA classified
- 2014-07-10
- Posted by FDA
- 2014-07-16
- Terminated
- 2015-03-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1430-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.