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Safety Alerts
September 28, 1999

Tussionex Pennkinetec Respiratory Medication Recalled

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.

QUANTITY

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 5/28/99.
Lot 90301: 7,702 units were distributed between 5/28/99 and 6/10/99.
Lot 90302: 7,714 units were distributed between 5/24/99 and 6/15/99.
Lot 90303: 3,166 units were distributed on 6/15/99
Lot 90309: 7,446 units were distributed between 5/25/99 and 6/10/99.
Lot 90310: 7,637 units were distributed between 6/10/99 and 6/30/99

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.

Safety Alerts compiles comprehensive safety recall information for the United States. SafeMail is a free email service to warn consumers of faulty products and contaminated foods. For complete information regarding current recalls, past recalls and timely product warning notification visit: www.safetyalerts.com.

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The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.