Reported Oct 12, 2022 · Terminated
Arformoterol Tartrate Inhalation Solution, 15 mcg/2mL, 2 mL Sterile Unit-Dose Vial packaged in 5 x 2 mL Sterile…
Cipla
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: CIPLA · 10 Independence Blvd · Warren, NJ · 07059-2730
Is this the product you have?
- 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 byCipla Ltd., Indore SEZ, Pithampur, India
- Manufactured forCipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059
- Lot codes and dates
- Batch No
IA10082IA10083IA10084IA10085IA10086exp. date 01/2023IA10122IA10123IA10124IA10125IA10126IA10127IA10128IA10129IA10130exp. date 02/2023
- Batch No
- Amount recalled
- 9041 cartons
Where it was sold
- Nationwide
Why it was recalled
Lack of Assurance of Sterility: environmental monitoring failure.
This product could cause temporary or reversible health problems — stop using it.
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