CIPLA: Drug Recall

Recall #D-1550-2022 · 09/29/2022

Class II: Risk

Recall Details

Recall Number: D-1550-2022
Classification: Class II
Product Type: Drug
Recalling Firm: CIPLA
Status: Terminated
Date Initiated: 09/29/2022
Location: Warren, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 9041 cartons

Reason for Recall

Lack of Assurance of Sterility: environmental monitoring failure.

Product Description

Arformoterol Tartrate Inhalation Solution, 15 mcg/2mL, 2 mL Sterile Unit-Dose Vial packaged in 5 x 2 mL Sterile Unit-Dose Vials per pouch, NDC 69097-168-48; 60 (12 x 5) x 2 mL Sterile Unit-Dose Vials per carton, NDC 69097-168-64, Rx Only, Manufactured by: Cipla Ltd., Indore SEZ, Pithampur, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059.

Distribution Pattern

Product was distributed nationwide to distributors/wholesalers who may have further distributed the product.

Other Recalls by CIPLA

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.
Class II: Risk 07/14/2022

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.

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.