Recalls / Class II
Class IID-396-2014
Product
Niacin Extended Release Tablets, USP, 500 mg, 90 count bottle, Rx Only, Teva Pharmaceuticals USA, Inc., Sellersville, PA, 18960, NDC 0093-7392-98
- Affected lot / code info
- Lot#: 32900349B, Exp: 12/2014
Why it was recalled
Failed Tablet/Capsule Specifications: There is a potential for broken tablets.
Recalling firm
- Firm
- Teva Pharmaceuticals USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 425 Privet Rd, Horsham, Pennsylvania 19044-1220
Distribution
- Quantity
- 10,512 bottles
- Distribution pattern
- Nationwide and Puerto Rico, American Samoa, Virgin Islands, and Canal Zone
Timeline
- Recall initiated
- 2013-11-26
- FDA classified
- 2014-01-02
- Posted by FDA
- 2014-01-08
- Terminated
- 2014-08-27
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-396-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.