August 18, 2017
SCA Pharmaceuticals is recalling fentanyl 10 mcg/mL in sodium chloride because of sterility concerns, according to the August 2, 2017, US Food and Drug Administration (FDA) Enforcement Report.
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The company is recalling the following, which were distributed throughout the United States:
- fentanyl 10 mcg/mL PF in sodium chloride 1-mL fill in 3-mL syringe (NDC 70004-0229-05) from lot 20170512@19 (beyond-use date 8/10/17); and
- fentanyl 10 mcg/mL PF in sodium chloride 250 mL (total dose 2500 mcg, NDC 70004-0229-40) from lots 20170509@20 (beyond-use date 8/7/17), 20170509@21 (beyond-use date 8/7/17), 20170509@46 (beyond-use date 8/7/17), and 20170511@33 (beyond-use date 8/9/17).
Citing the potential for the product to leak, SCA Pharmaceuticals voluntarily issued the recall July 14, 2017. It was designated Class II by the FDA July 26, 2017. Class II recalls indicate situations in which exposure to affected products may cause temporary or medically reversible adverse health consequences, but they are not likely to be serious.
An opioid medication, fentanyl is used as a part of anesthesia to prevent pain after surgery or other medical procedures.