May 24, 2000Baxter Pharmaceutical Products
Inc. Recalls Morphine Sulfate Injection
Providence, NJ (SafetyAlerts) - The
Food and Drug Administration (FDA) today reported that Baxter Pharmaceutical Products
Inc., is conducting a recall of Morphine Sulfate Injection, USP, 10 mg/mL, in 1 mL
dosette(r) ampule, because of the label incorrectly declares strength as (1/8 gr per mL)
not (1/6 gr per mL).
The Morphine Sulfate Injection is a
prescription potent analgesic and bears the Lot Number of 099077 EXP 9/02.
FDA stated in its report that 113,750
ampuls were distributed nationwide. The firm estimated that 3,657 ampuls remained on
market at time of recall initiation.
This Class III recall
was initiated by the company, by letter February 23, 2000. This is the first public
notice issued by the FDA. The report stated that the company had completed required
Questions concerning this recall may
be directed to the FDA at 1-888-INFO-FDA.
FDA Recall #d-351-0
Notice of this product warning was
sent via email to SafeMail
subscribers May 24, 2000.
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