Medications & Supplements/Prescription Drugs

Cipla Arformoterol Tartrate Inhalation Solution Recalled for Sterility Failure

Agency Publication Date: September 30, 2022

Summary

Cipla has recalled 9,041 cartons of Arformoterol Tartrate Inhalation Solution due to a failure in environmental monitoring that compromises the assurance of the product's sterility. This prescription medication, used to treat breathing conditions, was distributed in sterile unit-dose vials. While no injuries or adverse events have been reported to date, the use of a non-sterile inhalation drug poses a significant risk of infection.

Risk

A lack of sterility in an inhalation solution can lead to serious or life-threatening respiratory infections as contaminants are delivered directly into the lungs.

What You Should Do

This recall affects Arformoterol Tartrate Inhalation Solution (15 mcg/2mL) packaged in 2 mL sterile unit-dose vials under NDC codes 69097-168-48 (5-vial pouches) and 69097-168-64 (60-vial cartons).
Check your medication for the following lot numbers: IA10082, IA10083, IA10084, IA10085, IA10086 (expiration January 2023) or IA10122, IA10123, IA10124, IA10125, IA10126, IA10127, IA10128, IA10129, IA10130 (expiration February 2023).
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Arformoterol Tartrate Inhalation Solution (15 mcg/2mL)

Variants: 15 mcg/2mL, 2 mL Sterile Unit-Dose Vial, 5 x 2 mL vials per pouch, 60 x 2 mL vials per carton

Lot Numbers:

IA10082 (Exp 01/2023)

IA10083 (Exp 01/2023)

IA10084 (Exp 01/2023)

IA10085 (Exp 01/2023)

IA10086 (Exp 01/2023)

IA10122 (Exp 02/2023)

IA10123 (Exp 02/2023)

IA10124 (Exp 02/2023)

IA10125 (Exp 02/2023)

IA10126 (Exp 02/2023)

IA10127 (Exp 02/2023)

IA10128 (Exp 02/2023)

IA10129 (Exp 02/2023)

IA10130 (Exp 02/2023)

NDC:

69097-168-48

69097-168-64

Manufactured by Cipla Ltd., Indore SEZ, India; Manufactured for Cipla USA, Inc.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 90920

Status: Resolved

Manufacturer: CIPLA

Sold By: distributors; wholesalers

Manufactured In: India, United States

Units Affected: 9041 cartons

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects Arformoterol Tartrate Inhalation Solution (15 mcg/2mL) packaged in 2 mL sterile unit-dose vials under NDC codes 69097-168-48 (5-vial pouches) and 69097-168-64 (60-vial cartons).

Check your medication for the following lot numbers: IA10082, IA10083, IA10084, IA10085, IA10086 (expiration January 2023) or IA10122, IA10123, IA10124, IA10125, IA10126, IA10127, IA10128, IA10129, IA10130 (expiration February 2023).

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Arformoterol Tartrate Inhalation Solution (15 mcg/2mL)

Variants: 15 mcg/2mL, 2 mL Sterile Unit-Dose Vial, 5 x 2 mL vials per pouch, 60 x 2 mL vials per carton

Lot Numbers:

IA10082 (Exp 01/2023)

IA10083 (Exp 01/2023)

IA10084 (Exp 01/2023)

IA10085 (Exp 01/2023)

IA10086 (Exp 01/2023)

IA10122 (Exp 02/2023)

IA10123 (Exp 02/2023)

IA10124 (Exp 02/2023)

IA10125 (Exp 02/2023)

IA10126 (Exp 02/2023)

IA10127 (Exp 02/2023)

IA10128 (Exp 02/2023)

IA10129 (Exp 02/2023)

IA10130 (Exp 02/2023)

NDC:

69097-168-48

69097-168-64

Manufactured by Cipla Ltd., Indore SEZ, India; Manufactured for Cipla USA, Inc.