Exela Pharma Sciences LLC recalls Diclofenac Sodium and Misoprostol Delayed Release Tablets 75 mg/0.2 mg, 60-count bottle, Rx Only, Manufactured by: Cipla
Recalled May 30, 2018 · FDA recall D-0826-2018 · Exela Pharma Sciences
Hazard
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. · FDA Class II
Units
5256 bottles
Sold at
Nationwide in the USA and Puerto Rico
Description
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.
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.
Manufacturer(s)
Exela Pharma Sciences LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →