Class III · Low risk
Qnasl (beclomethasone dipropionate)
Failed Content Uniformity: Product was out of specification for spray content uniformity obtained during stability testing.
Children's Qnasl 40 mcg
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Content Uniformity Specifications: out of specification test result for spray content uniformity.
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
What was recalled
Children's Qnasl 40 mcg (beclomethasone dipropionate) Nasal Aerosol, 40 mcg per spray, 60 Metered Sprays per canister, 4.9g Net Contents, Rx only; Professional Sample; Manufactured for Teva Respiratory, LLC, Horsham, PA 19044; By: 3M Drug Delivery Systems, Northridge, CA 91324; NDC 59310-206-08.
Affected NDC
59310-0206-08
Compare with the code on your package — it is the most precise check available.
Drug: Beclomethasone
- Recalling firm
- Teva North America
- NDC code
- 59310-206-08
- Origin
- PA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1453-2016 · 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
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
Class III · Low risk
QVAR¿ (beclomethasone dipropionate HFA)
Failed Impurity/Degradation Specification; for 17-BMP at the 9 and 18 month stability time point
Other recalls by Teva North America
All 2016 recalls
Class III · Low risk
Claravis (isotretinoin capsules USP)
Failed Impurities/Degradation Specifications.
Class II · Moderate risk
Amoxicillin for Oral Suspension USP
Superpotent drug: Out of specification test result for assay during stability testing.
Class II · Moderate risk
Albuterol Sulfate Syrup
Presence of Foreign Substance; presence of black particles describes generically as cellulose-based bundles of brown fibrous material.
Class II · Moderate risk
Ondansetron Injection USP 40 mg/20 mL
CGMP Deviations
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