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May 31, 2000
Update September 27, 2000 - In Red

Morton Grove Pharmaceuticals  Recalls Promethazine Syrup Plain

Kansas City, MS (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that Morton Grove Pharmaceuticals is conducting a recall of Promethazine Syrup Plain, 6.25 mg/5mL in 4 and 16 ounce bottles,   packaged under the MGP (NDC #60432-608-16) and Major Pharmaceuticals (NDC#0904-1508-16) labels  because of subpotency (at stability testing).

The Urecholine is a prescription for the treatment of perennial and seasonal allergic rhinitis, vasomotor rhinitis, allergic reaction, sedation in both children and adults, and antiemetic therapy in posoperative patients. The product is coded with the Lot Numbers: 22086A, 22086C, 22086E.

Recall updated 9-27-00 to include:
Promethazine Syrup Plain, Rx, 6.25 mg/5 mL, 4 and 16 oz bottles, to
Lot 22086 as sub-lots A,C,E
Lot 22148 as sub-lots A,C,E,F, H
Lot 22345 as sub-lots A,C,E, F
Lot 22481 as sub-lots A,C
Lot 22623 as sub-lots A,C,E,F, H
Lot 22806 as sub-lots A,C,E, F
Lot 23020 as sub-lots A,C, E,F,K
Promethazine with Codeine Cough Syrup, Rx, (6.25mg/5mL and 10mg/5mL), in
4 fl. oz. bottles to include Lot 22649A.

FDA stated in its report that 7,224 4-ounce and 1,536 16-ounce bottles were distributed nationwide.  The firm estimated that 600 units remained on market at time of recall initiation.

This ongoing Class II 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-390-0
NDC #60432-608-16

Notice of this product warning was sent via email to SafeMail subscribers May 31, 2000.

Selected Recent Recalls

Health Professional:

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

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