Why it was recalled
Defective container: empty inhaler and leakage observed through the inhaler valve due to partially missing bottom seat (gasket).
Product description
Albuterol Sulfate Inhalation Aerosol, 90 mcg, 200 Metered Inhalation, net content 6.7 g canister packaged in a box, Rx only, Manufactured by: Cipla Ltd, Indore SE Z, Pithampur, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ, 07059, NDC 69097-142-60
Lot numbers, UPCs & expiration codes
Lot # IB20045, IB20055, IB20056, IB20057, IB20059, IB20072, Exp Nov. 30, 2023
Where it was sold
Nationwide in the US
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-0938-2023
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Jun 27, 2023
- FDA report date
- Jul 19, 2023
- Quantity
- 278,538 canisters
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Cipla USA, Inc.
Original FDA data
Every field from FDA enforcement report D-0938-2023, exactly as published.
Show all FDA fields
- City
- Warren
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 92616
- Address
- 10 Independence Blvd
- Code information
- Lot # IB20045, IB20055, IB20056, IB20057, IB20059, IB20072, Exp Nov. 30, 2023
- Postal code
- 07059-2730
- Report date
- Jul 19, 2023
- Product type
- Drugs
- Recall number
- D-0938-2023
- Classification
- Class I
- Recalling firm
- Cipla USA, Inc.
- Product quantity
- 278,538 canisters
- Termination date
- Mar 6, 2025
- Reason for recall
- Defective container: empty inhaler and leakage observed through the inhaler valve due to partially missing bottom seat (gasket).
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Albuterol Sulfate Inhalation Aerosol, 90 mcg, 200 Metered Inhalation, net content 6.7 g canister packaged in a box, Rx only, Manufactured by: Cipla Ltd, Indore SE Z, Pithampur, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ, 07059, NDC 69097-142-60
- Distribution pattern
- Nationwide in the US
- Recall initiation date
- Jun 27, 2023
- Initial firm notification
- Letter
- Center classification date
- Jul 21, 2023