May 24, 2000Morton Grove Pharmaceuticals
Recalls Promethazine VC Plain Syrup
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
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)
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 -
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.
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