Why it was recalled
Lack of Assurance of Sterility: environmental monitoring failure.
Product 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.
Lot numbers, UPCs & expiration codes
Batch 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 sold
Product was distributed nationwide to distributors/wholesalers who may have further distributed the product.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1550-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 29, 2022
- FDA report date
- Oct 12, 2022
- Quantity
- 9041 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- CIPLA
Original FDA data
Every field from FDA enforcement report D-1550-2022, exactly as published.
Show all FDA fields
- City
- Warren
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 90920
- Address
- 10 Independence Blvd
- Code information
- Batch No: IA10082, IA10083, IA10084, IA10085, IA10086, exp. date 01/2023; IA10122, IA10123, IA10124, IA10125, IA10126, IA10127, IA10128, IA10129, IA10130, exp. date 02/2023
- Postal code
- 07059-2730
- Report date
- Oct 12, 2022
- Product type
- Drugs
- Recall number
- D-1550-2022
- Classification
- Class II
- Recalling firm
- CIPLA
- Product quantity
- 9041 cartons
- Termination date
- Jul 25, 2023
- Reason for recall
- Lack of Assurance of Sterility: environmental monitoring failure.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product 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.
- Distribution pattern
- Product was distributed nationwide to distributors/wholesalers who may have further distributed the product.
- Recall initiation date
- Sep 29, 2022
- Initial firm notification
- Letter
- Center classification date
- Sep 30, 2022