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May 31, 2000

Morton Grove Pharmaceuticals is Recalling Certain Lots of Promethazine with Codeine Cough Syrup

Morton Grove, IL (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that Morton Grove Pharmaceuticals is recalling Promethazine with Codeine Cough Syrup, 6.25 mg/5mL and 10 mg/5mL, in
4-fluid ounce bottles, because of subpotency (at stability testing).

The product is a prescription medication for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold, and can be identified by lot #22649A.

FDA stated in its report that 4,128 bottles were distributed nationwide.

This ongoing Class III recall was initiated by the company, by letter dated May 11, 2000.  This is the first public notice issued by the FDA.

Questions concerning this recall may be directed to the FDA at 1-888-INFO-FDA.
FDA Recall #d-391-0
NDC #60432-606-04.

Selected Recent Recalls

Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

How many did you hear about?

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