Why it was recalled
Failed Impurities/Degradation Specifications: high out of specification results for related compound D.
Product description
Albuterol Sulfate Inhalation Solution, 0.021% (0.63 mg/3mL), packaged in 5 pouches of 5 x 3mL Sterile Unit-Dose Vials For Inhalation per carton, Rx only, Mfd. for: Watson Laboratories, Inc., Corona, CA 92880; Mfd. by: Cipla Ltd., Verna, Goa INDIA, NDC 0591-3467-53.
Lot numbers, UPCs & expiration codes
Lot #s: GA60206, GA60207, Exp 08/17; GA60283, GA60284, Exp 09/17; GA60378, GA60379, GA60478, Exp 10/17; GA60491, Exp 11/17; GA60615, GA60616, Exp 12/17; GA60719, GA60720, GA60721, GA60749, GA60750, GA60751, Exp 01/18; GA70001, GA70031, GA70046, GA70047, GA70074, GA70075, Exp 06/18
Where it was sold
Nationwide in the USA and Puerto Rico
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-1039-2017
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jul 25, 2017
- FDA report date
- Aug 9, 2017
- Quantity
- 401,750 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA
Original FDA data
Every field from FDA enforcement report D-1039-2017, exactly as published.
Show all FDA fields
- City
- North Wales
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 77832
- Address
- 1090 Horsham Rd
- Code information
- Lot #s: GA60206, GA60207, Exp 08/17; GA60283, GA60284, Exp 09/17; GA60378, GA60379, GA60478, Exp 10/17; GA60491, Exp 11/17; GA60615, GA60616, Exp 12/17; GA60719, GA60720, GA60721, GA60749, GA60750, GA60751, Exp 01/18; GA70001, GA70031, GA70046, GA70047, GA70074, GA70075, Exp 06/18
- Postal code
- 19454-1505
- Report date
- Aug 9, 2017
- Product type
- Drugs
- Recall number
- D-1039-2017
- Classification
- Class III
- Recalling firm
- Teva Pharmaceuticals USA
- Product quantity
- 401,750 cartons
- Termination date
- Apr 26, 2018
- Reason for recall
- Failed Impurities/Degradation Specifications: high out of specification results for related compound D.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Albuterol Sulfate Inhalation Solution, 0.021% (0.63 mg/3mL), packaged in 5 pouches of 5 x 3mL Sterile Unit-Dose Vials For Inhalation per carton, Rx only, Mfd. for: Watson Laboratories, Inc., Corona, CA 92880; Mfd. by: Cipla Ltd., Verna, Goa INDIA, NDC 0591-3467-53.
- Distribution pattern
- Nationwide in the USA and Puerto Rico
- Recall initiation date
- Jul 25, 2017
- Initial firm notification
- Letter
- Center classification date
- Jul 31, 2017