ARFORMOTEROL TARTRATE Recall D-1550-2022
Description: 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.
ARFORMOTEROL TARTRATE Recall D-1550-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1550-2022 |
| Event ID | 90920 |
| Brand | ARFORMOTEROL TARTRATE |
| Generic Name | ARFORMOTEROL TARTRATE |
| Manufacturer | ARFORMOTEROL TARTRATE |
| Original Package? | 1 |
| Active Substance | ARFORMOTEROL TARTRATE |
| Drug Route | RESPIRATORY (INHALATION) |
| Distribution | Product was distributed nationwide to distributors/wholesalers who may have further distributed the product. |
| Quantity | 9041 cartons |
| Recall Reason | Lack of Assurance of Sterility: environmental monitoring failure. |
| Drug Classification | Class II |
| Drug Code Info | 20221012 |
| Product NDC | 69097-168 |
| Recall Initiation Date | 20220929 |
| Report Date | 20221012 |
| Classification Date | 20220930 |
| Address | 10 Independence Blvd Warren, NJ 07059-2730 United States |
| Recalling Firm | CIPLA |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 5P8VJ2I235 |
| Drug Application Number | ANDA207306 |
| Structured Product Labeling (SPL ID) | b4866add-e9d7-4933-988a-256ecc149be9 |
| Structured Product Labeling (SPL Set ID) | 70071afd-5323-4019-aca5-5534278829dc |
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