Recalls / Class II
Class IID-335-2014
Product
Lescol XL (fluvastatin sodium) Extended-Release Tablets, 80 mg per tablet, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC # 0078-9354-07
- Affected lot / code info
- Product code: 707136; Lot Number: F0017, Exp 01/31/2015
Why it was recalled
Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves.
Recalling firm
- Firm
- Novartis Pharmaceuticals Corp.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 25 Old Mill Rd, Suffern, New York 10901-4106
Distribution
- Quantity
- 46,812 bottles
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2013-08-08
- FDA classified
- 2013-12-06
- Posted by FDA
- 2013-12-18
- Terminated
- 2015-12-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-335-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.