# FDA recall D-1550-2022

> **CIPLA** · Class II · drug recall initiated 2022-09-29.

## 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 for recall

Lack of Assurance of Sterility: environmental monitoring failure.

## Distribution

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

## Key facts

- **Recall number:** D-1550-2022
- **Recalling firm:** CIPLA
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-09-29
- **Report date:** 2022-10-12
- **Termination date:** 2023-07-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Warren, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1550-2022

## Citation

> AI Analytics. FDA recall D-1550-2022. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/D-1550-2022. Source: US FDA. Licensed CC0.

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