Why it was recalled
Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant.
Product description
Albuterol Sulfate Inhalation Solution, USP, 0.021% (0.63 mg / 3 mL), 3mL Vials, Rx only, Mfd. for Watson Laboratories Inc., Corona, CA 92880 USA, Mfd. by Cipla Ltd. Verna, Goa India, NDC 0591-3467-53
Lot numbers, UPCs & expiration codes
Lot #: GA51265, Ex[p. Jan-2017, GA51454, GA51553, GA51583, Exp. Feb-2017, GA51598, GA51724, GA51725, GA51749, Exp. Mar-2017
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-0439-2017
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jan 12, 2017
- FDA report date
- Feb 1, 2017
- Quantity
- 164,844 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Actavis Inc
Original FDA data
Every field from FDA enforcement report D-0439-2017, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 76229
- Address
- 400 Interpace Pkwy
- Code information
- Lot #: GA51265, Ex[p. Jan-2017, GA51454, GA51553, GA51583, Exp. Feb-2017, GA51598, GA51724, GA51725, GA51749, Exp. Mar-2017
- Postal code
- 07054-1120
- Report date
- Feb 1, 2017
- Product type
- Drugs
- Recall number
- D-0439-2017
- Classification
- Class III
- Recalling firm
- Actavis Inc
- Product quantity
- 164,844 units
- Termination date
- Mar 5, 2018
- Reason for recall
- Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Albuterol Sulfate Inhalation Solution, USP, 0.021% (0.63 mg / 3 mL), 3mL Vials, Rx only, Mfd. for Watson Laboratories Inc., Corona, CA 92880 USA, Mfd. by Cipla Ltd. Verna, Goa India, NDC 0591-3467-53
- Distribution pattern
- Nationwide in the US
- Recall initiation date
- Jan 12, 2017
- Initial firm notification
- Letter
- Center classification date
- Jan 24, 2017