Esomeprazole Magnesium for Delayed-Release Oral Suspension 10mg, packaged in unit dose packets, R...
FDA Recall #D-0181-2021 — Class II — December 17, 2020
Product Description
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
Recalling Firm
CIPLA — Warren, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
284,610 packets
Distribution
U.S.A. Nationwide
Code Information
Lot #: KA00411, KA00412, KA00460, Exp 11/2021
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated