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May 24, 2000

Morton Grove Pharmaceuticals Recalls Promethazine VC Plain Syrup

Morton Grove, IL (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that Morton Grove Pharmaceuticals is conducting a recall of Promethazine VC Plain Syrup, (6.25mg/5mL and 5 mg/5mL), in 4-ounce and 16-ounce (pint) bottles, because of subpotency of the Promethazine Hydrochloride ingredient.

The recalled Promethazine VC Plain Syrup is a oral prescription intended for the temporary relief of upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.   This recall affects Lot 22110 (sublots A,C,E) EXP 04/00 and lot 22227(sublots A,C,E,F,H,K) EXP 06/00.

FDA stated in its report that over 39,000 bottles were distributed nationwide under the following labels:

a) MGP, 4-ounce - NDC #60432-605-04, 16-ounce - NDC #60432-605-16

b) Major Pharmaceuticals, 16-ounce - NDC #0904-1512-16

c) Qualitest, 4-ounce - NDC #0603-1582-54, 16-unce - NDC #0603-1582-58.

This ongoing Class III recall was initiated by the company, by letter dated May 2, 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-342-0

Notice of this product warning was sent via email to SafeMail subscribers May 24, 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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