FDA-Drug2018-05-30Class II
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.
Exela Pharma Sciences LLC
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.
Sold states
Nationwide in the USA and Puerto Rico
Affected count
5256 bottles
Manufactured in
1245 Blowing Rock Blvd, N/A, Lenoir, NC, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0826-2018Don't want to check this manually?
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