Recall: D-1550-2022

Class II - Potentially Harmful

Class IIClassification

2022-09-29Initiated

TerminatedStatus

CIPLAFirm

Product

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.

Reason

Lack of Assurance of Sterility: environmental monitoring failure.

Distribution

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

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.