Drug recall D-0181-2021

Class II Terminated reported Jan 6, 2021

Product

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

Reason for recall

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

Lots and codes

Lot #: KA00411, KA00412, KA00460, Exp 11/2021

Recall details

Recalling firm
CIPLA, Warren, NJ
Quantity
284,610 packets
Distribution
U.S.A. Nationwide
Type
Voluntary: Firm initiated
Recall initiated
December 17, 2020
Terminated
December 7, 2022

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