May 31, 2000Morton Grove
Pharmaceuticals is Recalling Certain Lots of Promethazine with Codeine Cough Syrup
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
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