Morton Grove Pharmaceuticals Recalls Promethazine with Codeine Cough Syrup

Morton 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 Hydrochloride ingredient.

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 cold,
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 #0182-1712-40

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.

Safety Alerts compiles comprehensive safety recall information for the United States. SafeMail is a free email service to warn consumers of faulty products and contaminated foods. For complete information regarding current recalls, past recalls and timely product warning notification visit: www.safetyalerts.com.

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