Why it was recalled
Failed Impurities/Degradation Specifications: out of specification test results for an impurity during stability testing.
Product description
QVAR (beclomethasone dipropionate HFA 40 mcg), 40 mcg Inhalation Aerosol, For Oral Inhalation with QVAR Actuator Only, 120 metered inhalations, Rx Only, Mktd by Teva Respiratory, LLC., Horsham, PA. mfd by 3M Drug Delivery Systems, Northridge, CA, NDC 59310-0202-12
Lot numbers, UPCs & expiration codes
Lot #s:130449, 130450; Exp. Date: 12/2015
Where it was sold
Nationwide and Peurto 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-1087-2015
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- May 7, 2015
- FDA report date
- Jun 3, 2015
- Quantity
- 233,364 Inhalers
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA
Original FDA data
Every field from FDA enforcement report D-1087-2015, exactly as published.
Show all FDA fields
- City
- Horsham
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 71140
- Address
- 425 Privet Rd
- Code information
- Lot #s:130449, 130450; Exp. Date: 12/2015
- Postal code
- 19044-1220
- Report date
- Jun 3, 2015
- Product type
- Drugs
- Recall number
- D-1087-2015
- Classification
- Class III
- Recalling firm
- Teva Pharmaceuticals USA
- Product quantity
- 233,364 Inhalers
- Termination date
- Nov 15, 2016
- Reason for recall
- Failed Impurities/Degradation Specifications: out of specification test results for an impurity during stability testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- QVAR (beclomethasone dipropionate HFA 40 mcg), 40 mcg Inhalation Aerosol, For Oral Inhalation with QVAR Actuator Only, 120 metered inhalations, Rx Only, Mktd by Teva Respiratory, LLC., Horsham, PA. mfd by 3M Drug Delivery Systems, Northridge, CA, NDC 59310-0202-12
- Distribution pattern
- Nationwide and Peurto Rico
- Recall initiation date
- May 7, 2015
- Initial firm notification
- Letter
- Center classification date
- May 28, 2015