Drug product
Welchol Tablets (colesevelam HCl) 625 mg, 180 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 ---NDC 65597-701-18
D-1505-2014
Product summary
- Event
- Event 68793
- Status
- Terminated
- Classification
- Class II
- Quantity
- 68 bottles
- Official record key
drug-enforcement:D-1505-2014
Official wording
Reason: Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
Code information: Lot NVWG Exp - 11/30/2016
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping