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Class II · ModerateRecall completed

Arformoterol Tartrate

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberBatch No: IA10082, IA10083, IA10084, IA10085, IA10086, exp. date 01/2023; IA10122, IA10123, IA10124, IA10125, IA10126, IA10127, IA10128, IA10129, IA10130, exp. date 02/2023
Where it was soldProduct was distributed nationwide to distributors/wholesalers who may have further distributed the product.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Lack of Assurance of Sterility: environmental monitoring failure.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byCipla Ltd., Indore SEZ, Pithampur, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059 foreign manufacturer
Brand nameARFORMOTEROL TARTRATE
Generic nameARFORMOTEROL TARTRATE
Active ingredient(s)ARFORMOTEROL TARTRATE
Distributed by / forCipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059
NDC69097-168-48
Show the full FDA record
Full product labelArformoterol 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.
Recalling firmCIPLA
DistributionProduct was distributed nationwide to distributors/wholesalers who may have further distributed the product.
Quantity9041 cartons
Recall initiated2022-09-29
Report date2022-10-12
Recall completed2023-07-25
Recall numberD-1550-2022
ClassificationClass II
FDA statusTerminated
Origin on fileWarren NJ United States

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.