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.
FDA recall notice · announced May 30, 2018 · Exela Pharma Sciences
Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.
The 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.
Reason for recall
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.
Notes
Distribution: Nationwide in the USA and Puerto Rico
Lot/code information: Lot: GH70154, Exp 12/18
Quantity: 5256 bottles
Status: Terminated
Products in this recall event:
- 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, ND (D-0826-2018)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.