Drug Enforcement D-382-2014

Defective Delivery System: There is a potential for some units in certain lots of Qnasl Nasal Aerosol 80 mcg metered spray to have clogged stem valves.

Status

Terminated

Classification

Class III

Report Date

January 1, 2014

Termination Date

August 27, 2014

Product Information

Product description
Qnasl (beclomethasone dipropionate) Nasal Aerosol, 80 mcg per spray, 120 metered sprays, 8.7 g inhaler, Rx only, Manufactured for Teva Respiratory, LLC, Horsham, PA 19044; By: 3M Delivery Systems, Northridge, CA 91324, NDC 59310-210-12, UPC 3 59310 21012 9.
Product quantity
379,463 inhalers
Reason for recall
Defective Delivery System: There is a potential for some units in certain lots of Qnasl Nasal Aerosol 80 mcg metered spray to have clogged stem valves.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide and Puerto Rico

Location & Firm

Recalling firm
Teva Pharmaceuticals USA
Address
425 Privet Rd, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-382-2014
Event ID
67010
Recall initiation date
December 4, 2013
Center classification date
December 20, 2013
Code info
Lot #: 120004, Exp 01/14; 120095, 120131, 120131 2, Exp 03/14; 120271, Exp 07/14; 120351, Exp 08/14
More code info
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