Esomeprazole Magnesium for Delayed-Release Oral Suspension 20mg, 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 69097-528-34
Recall Number: D-0182-2021
Firm: CIPLA
Classification: Class II
Status: Terminated
Report Date: 20210106
Initiation Date: 20201217
Termination Date: 20221207
Reason for Recall
Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
Product Description
Esomeprazole Magnesium for Delayed-Release Oral Suspension 20mg, 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 69097-528-34