February 01, 2019
A labeling error has prompted Advanced Pharma Inc. to issue a recall for 160 single-use syringes containing heparin injectable solution, according to the January 30, 2019, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects heparin 50 mg/50 mL (1 mg/mL) injectable solution, heparin sodium 0.45% sodium chloride QS heparin 50 units 50 mL (NDC 42852-725-65). The label incorrectly lists the concentration as 50 mg/50 mL (1 mg/mL); the accurate concentration is 50 units/50 mL (1 unit/mL).
The recalled syringes are from lot 12/19/18 0242 72565S (BUD 3/31/19), which was distributed in Texas and Washington.
Advanced Pharma voluntarily initiated the recall January 15, 2019. At press time, the FDA had not yet issued a classification for the recall.
Heparin is an anticoagulant used to prevent and treat blood clots.
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