Arformoterol Tartrate Solution
FDA Recall NDC 69097-168
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Arformoterol Tartrate (NDC 69097-168). A significant event, classified as Class II, was initiated on Sep 29, 2022 by Cipla Usa Inc.. The reported reason for this action was: "Lack of Assurance of Sterility: environmental monitoring failure."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Lack of Assurance of Sterility: environmental monitoring failure.
Sep 29, 2022
Oct 12, 2022
9041 cartons
Recall Profile & Regulatory Data
Event ID
90920
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
CIPLA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed nationwide to distributors/wholesalers who may have further distributed the product.
Termination Date
Jul 25, 2023
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.
Batch or Lot Expiration Information
Batch# Batch No: IA10082, IA10083, IA10084, IA10085, IA10086, exp. date 01/2023; IA10122, IA10123, IA10124, IA10125, IA10126, IA10127, IA10128, IA10129, IA10130, exp. date 02/2023
Affected Packages Involved in this Recall
69097-168-48Product
69097-168-87Product
69097-168-64Product
69097-168-32Product
69097-168-53Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
