Exela Pharma Sciences LLC recalls Diclofenac Sodium and Misoprostol Delayed Release Tablets 75 mg/0.2 mg, 60-count bottle, Rx Only, Manufactured by: Cipl…

Recall date

April 20, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0826-2018

FDA classification

Class II

Brand / firm

Exela Pharma Sciences LLC

Sold / distributed

Nationwide in the USA and Puerto Rico

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.