May 24, 2000Morton Grove Pharmaceuticals
Recalls Promethazine with Codeine Cough Syrup
Grove, IL (SafetyAlerts) - The Food
and Drug Administration (FDA) today reported that Morton Grove Pharmaceuticals is
conducting a recall of Promethazine with Codeine Cough Syrup (6.25 mg/5 mL and 10 mg/5
mL), in 4 and 16-fluid ounce (pint) bottles, because of subpotency of the Promethazine
The recalled Promethazine with
Codeine Cough Syrup is a prescription, schedule V narcotic oral liquid for the temporary
relief of coughs and upper respiratory symptoms associated with allergy or the common
under the following labels:
a) MGP, 4-ounce - NDC #60432-606-04
and 16-ounce - NDC #60432-606-16
b) Zenith Goldline, 16-ounce - NDC
c) Major Pharmaceuticals, 4-ounce -
NDC #0904-1510-00 and 16-ounce - NDC #0904-1510-16
d) Qualitest, 4-ounce - NDC
#0603-1578-54 and 16-ounce - NDC #0603-1578-58
e) URL, 16-ounce - NDC #0677-0963-33.
FDA stated in its report that over
225,000 bottles were distributed nationwide and bear the Lot Numbers: 22128, 22161, 22238,
22295, 22369, 22500 and 22555. The firm estimated that less than 20% of the product
remained on market at time of recall initiation.
This ongoing Class III recall
was initiated by the company, by letter dated March 28, 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-340-0
Notice of this product warning was
sent via email to SafeMail
subscribers May 24, 2000.
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