CIPLA recalls Esomeprazole Magnesium for Delayed-Release Oral Suspension 10mg, packaged in unit dose packets, Rx only, Manufactured b…

Recall date

December 17, 2020

Source

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

Recall number

D-0181-2021

FDA classification

Class II

Brand / firm

CIPLA

Sold / distributed

U.S.A. Nationwide

Why it was recalled

Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline

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

What was recalled

Esomeprazole Magnesium for Delayed-Release Oral Suspension 10mg, packaged in unit dose packets, Rx only, Manufactured by: Cipla Ltd., Kurkumbh, India, Manufactured for: Cipla USA, Inc. 10 Independence Boulevard, Suite 300 Warren, NJ 07059, NDC 69097-527-34