FDA Drug Class II — Moderate

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

Hazard

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

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Products

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
Brand
CIPLA
UPC
Lot #: KA00411, KA00412, KA00460, Exp 11/2021

Units Affected

284,610 packets

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