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
Recall initiated: 20201217
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated