CIPLA: Drug Recall

Recall #D-0165-2021 · 12/14/2020

Class II: Risk

Recall Details

Recall Number: D-0165-2021
Classification: Class II
Product Type: Drug
Recalling Firm: CIPLA
Status: Terminated
Date Initiated: 12/14/2020
Location: Warren, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 2151 vials

Reason for Recall

cGMP deviations: Vials may not be sealed correctly affecting sterility.

Product Description

Azacitidine for Injection 100 mg/vial For Subcutaneous and Intravenous Use Only Single-Dose Vial Manufactured by Shilpa Medicare Limited Jadcherla -509301 INDIA Distributed by: Cipla USA, Inc. 10 Independence Blvd, Suite 300 Warren, NJ 07059 NDC 69097-805-40

Distribution Pattern

USA 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.