Reported Apr 9, 2014 · Terminated
QVAR¿ (beclomethasone dipropionate HFA), C4 INHALATION AEROSOL in Aluminum Cylinders, Mktd by: Teva Respiratory, LLC,…
Teva Pharmaceuticals USA
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Teva Pharmaceuticals USA · 425 Privet Rd · Horsham, PA · 19044-1220
Is this the product you have?
- QVAR¿ (beclomethasone dipropionate HFA), C4 INHALATION AEROSOL in Aluminum Cylinders
- Mktd byTeva Respiratory, LLC, Horsham
- PA 19044 Mfd by
3M Drug Delivery SystemsNorthridgeCA 91324
- Lot codes and dates
lot 120088exp.3/2014NDC 59310-202-4040 mcg8.7g / 120 metered inhalationslot 120491exp. 10/2014NDC 59310-175-4140 mcg7.3g / 100 metered inhalations
- Amount recalled
- 257,832 cylinders
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was recalled
Failed Impurity/Degradation Specification; for 17-BMP at the 9 and 18 month stability time point
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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