CIPLA: Drug Recall

Recall #D-0182-2021 · 12/17/2020

Class II: Risk

Recall Details

Recall Number: D-0182-2021
Classification: Class II
Product Type: Drug
Recalling Firm: CIPLA
Status: Terminated
Date Initiated: 12/17/2020
Location: Warren, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 289350 packets

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

Distribution Pattern

U.S.A. Nationwide

Other Recalls by CIPLA

Class II: Risk 09/29/2022

Lack of Assurance of Sterility: environmental monitoring failure.
Class II: Risk 09/15/2022

Lack of Assurance of Sterility
Class II: Risk 08/22/2022

Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility.
Class II: Risk 08/22/2022

Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility.
Class II: Risk 08/02/2022

Lack of Assurance of Sterility: Complaints received of defective container closure.

View all recalls by CIPLA →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.