Class III · Low risk
Qnasl (beclomethasone dipropionate)
Failed Content Uniformity: Product was out of specification for spray content uniformity obtained during stability testing.
QVAR¿ (beclomethasone dipropionate HFA)
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Impurity/Degradation Specification; for 17-BMP at the 9 and 18 month stability time point
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
What was recalled
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.
Drug: Beclomethasone
- Recalling firm
- Teva Pharmaceuticals USA
- Origin
- PA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1190-2014 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Beclomethasone recalls
See all
Class III · Low risk
Qnasl (beclomethasone dipropionate)
Failed Content Uniformity: Product was out of specification for spray content uniformity obtained during stability testing.
Class III · Low risk
Children's Qnasl 40 mcg
Failed Content Uniformity Specifications: out of specification test result for spray content uniformity.
Class III · Low risk
QVAR (beclomethasone dipropionate HFA 40 mcg)
Failed Impurities/Degradation Specifications: out of specification test results for an impurity during stability testing.
Class II · Moderate risk
QVAR¿ (beclomethasone dipropionate HFA)
Defective Delivery System; defective valve
Other recalls by Teva Pharmaceuticals USA
All 2014 recalls
Class II · Moderate risk
traZODone Hydrochloride Tablets
Presence of Foreign Tablets/Capsules
Class II · Moderate risk
Octreotide Acetate for Injectable Suspension
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Class II · Moderate risk
Claravis (isotretinoin capsule, USP)
Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
Class II · Moderate risk
Clonidine Transdermal System
CGMP Deviations: use of an unapproved raw material
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