FDA recall D-0183-2021

Product

Esomeprazole Magnesium for Delayed-Release Oral Suspension 40mg, 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 69097-529-34

Reason for recall

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

Distribution

U.S.A. Nationwide

Key facts

Status

Terminated

Initiation date

2020-12-17

Report date

2021-01-06

Termination date

2022-12-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Warren, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0183-2021