September 28, 1999
Tussionex Pennkinetec Respiratory Medication
Rochester, NY (SafetyAlerts) - The FDA today issued
notice that Medeva Pharmaceuticals Inc., of Rochester, New York, is continuing it recall
of Tussionex Pennkinetic due to microbial contamination (acetobacter SPP).
According to the FDA the product was distributed
nationwide between 5/17/99 and 6/30/99.
Medeva initiated the recall by letter dated August
6, 1999. The FDA's description of the product is as follows:
"TUSSIONEX Pennkinetic (hydrocodone
polistirex), extended- release suspension (Hydrocodone polistirex equivalent to 10 mg
hydrocodone bitartrate and Chlorpheniramine polistirex equivalent to 8 mg chlorpheniramine
maleate), in 473 mL bottle, Rx medication for relief of cough and upper respiratory
symptoms associated with allergy or a cold. NDC #53014-548-67."
The product identification codes are listed below:
90299, EXP 04/01
90300, EXP 04/01
90301, EXP 04/01
90302, EXP 04/01
90303, EXP 04/01
90309, EXP 05/01
90310, EXP 05/01.
This recall has been certified as a 'Class II' recall by the FDA.
Lot 90299: 7,491 units were
distributed between 5/17/99 and 5/19/99.
Lot 90300: 7,622 units were distributed between 5/18/99 and
Lot 90301: 7,702 units were distributed between 5/28/99 and
Lot 90302: 7,714 units were distributed between 5/24/99 and
Lot 90303: 3,166 units were distributed on 6/15/99
Lot 90309: 7,446 units were distributed between 5/25/99 and
Lot 90310: 7,637 units were distributed between 6/10/99 and
Questions concerning this recall may be directed
to the Food and Drug Administration at 1-800-INFO-FDA. The reference number is: #D-423-9.
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