Drug product
Furosemide Tablets USP, 20 mg, 1000 count bottles, Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-4297-31.
D-0437-2017
Product summary
- Event
- Event 76142
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6493 bottles
- Official record key
drug-enforcement:D-0437-2017
Official wording
Reason: Failed Tablet/Capsule Specifications: An unusually thick tablet was reported through a complaint.
Code information: Lot# 660833A, Exp 08/31/18
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Unknown
Failed Tablet/Capsule Specifications: An unusually thick tablet was reported through a complaint.