Drug product
Diclofenac Sodium and Misoprostol Delayed Release Tablets 75 mg/0.2 mg, 60-count bottle, Rx Only, Manufactured by: Cipla Ltd., India; For: EAGLE PHARMACEUTICALS, INC., Woodcliff Lake, NJ 07677 USA, NDC 42367-111-06.
D-0826-2018
Product summary
- Event
- Event 79969
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5256 bottles
- Official record key
drug-enforcement:D-0826-2018
Official wording
Reason: Labeling: Label Mix-Up: bottle labeled as Diclofenac Sodium and Misoprostol 75 mg/0.2 mg contained Diclofenac Sodium and Misoprostol 50 mg/0.2 mg tablets.
Code information: Lot: GH70154, Exp 12/18
Distribution pattern: Nationwide in the USA and Puerto Rico
Derived failure modes
-
Labeling or packaging
Labeling: Label Mix-Up