FDA-Drug2021-01-06Class II
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
CIPLA
Hazard
Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
Sold states
U.S.A. Nationwide
Affected count
284,610 packets
Manufactured in
10 Independence Blvd, N/A, Warren, NJ, United States
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 Boulevard, Suite 300 Warren, NJ 07059, NDC 69097-527-34
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0181-2021Don't want to check this manually?
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