Recall: D-0183-2021

Class II - Potentially Harmful

Class IIClassification

2020-12-17Initiated

TerminatedStatus

CIPLAFirm

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

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

Distribution

U.S.A. Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.