May 31, 2000
Update September 27, 2000 - In RedMorton
Grove Pharmaceuticals Recalls Promethazine Syrup Plain
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.
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
Notice of this product warning was
sent via email to SafeMail
subscribers May 31, 2000.
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