Recalls / Class II
Class IID-1505-2014
Product
Welchol Tablets (colesevelam HCl) 625 mg, 180 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 ---NDC 65597-701-18
- Affected lot / code info
- Lot NVWG Exp - 11/30/2016
Why it was recalled
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
Recalling firm
- Firm
- Daiichi Sankyo Pharma Development
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 399 Thornall St, Edison, New Jersey 08837-2236
Distribution
- Quantity
- 68 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-07-12
- FDA classified
- 2014-07-31
- Posted by FDA
- 2014-08-06
- Terminated
- 2015-03-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1505-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.