Why it was recalled
Failed Impurity/Degradation Specification; for 17-BMP at the 9 and 18 month stability time point
Product description
QVAR¿ (beclomethasone dipropionate HFA), C4 INHALATION AEROSOL in Aluminum Cylinders, Mktd by: Teva Respiratory, LLC, Horsham, PA 19044 Mfd by: 3M Drug Delivery Systems, Northridge, CA 91324.
Lot numbers, UPCs & expiration codes
lot 120088, exp.3/2014, NDC 59310-202-40, 40 mcg,8.7g / 120 metered inhalations, lot 120491, exp. 10/2014, NDC 59310-175-41,40 mcg,7.3g / 100 metered inhalations
Where it was sold
Nationwide
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-1190-2014
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Feb 11, 2014
- FDA report date
- Apr 9, 2014
- Quantity
- 257,832 cylinders
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA
Original FDA data
Every field from FDA enforcement report D-1190-2014, exactly as published.
Show all FDA fields
- City
- Horsham
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 67564
- Address
- 425 Privet Rd
- Code information
- lot 120088, exp.3/2014, NDC 59310-202-40, 40 mcg,8.7g / 120 metered inhalations, lot 120491, exp. 10/2014, NDC 59310-175-41,40 mcg,7.3g / 100 metered inhalations
- Postal code
- 19044-1220
- Report date
- Apr 9, 2014
- Product type
- Drugs
- Recall number
- D-1190-2014
- Classification
- Class III
- Recalling firm
- Teva Pharmaceuticals USA
- Product quantity
- 257,832 cylinders
- Termination date
- Nov 14, 2014
- Reason for recall
- Failed Impurity/Degradation Specification; for 17-BMP at the 9 and 18 month stability time point
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- QVAR¿ (beclomethasone dipropionate HFA), C4 INHALATION AEROSOL in Aluminum Cylinders, Mktd by: Teva Respiratory, LLC, Horsham, PA 19044 Mfd by: 3M Drug Delivery Systems, Northridge, CA 91324.
- Distribution pattern
- Nationwide
- Recall initiation date
- Feb 11, 2014
- Initial firm notification
- Telephone
- Center classification date
- Apr 3, 2014