January 05, 2018
Sterility assurance concerns have prompted SSM Health Care St. Louis, which does business as SSM St. Clare Health Center, to voluntarily initiate several medication recalls for compounded injectable drugs distributed in Missouri.
According to the January 3, 2018, US Food and Drug Administration (FDA) Enforcement Report, microbial growth occurred during a routine manufacturing simulation. However, at this point, no distributed medications have been identified as actually containing microorganisms.
The recall affects the following 4 compounded injectable drugs for use in hospitals and medical offices:
- fentanyl 10 mcg in 0.9% sodium chloride 1 mL, 1-mL vial (concentration 10 mcg/mL, NDC 88890-9010-81), from lot 170614-006 (Exp. 9/12/17);
- fentanyl 2 mcg/mL and ropivacaine 0.2% in 0.9% sodium chloride 150 mL, 150-mL bag (NDC 88883-4272-01), from lots 170621-008 (Exp. 9/19/17), 170703-002 (Exp. 10/1/17), and 170711-031 (Exp. 10/9/17);
- amiodarone 900 mg in dextrose 5% 500 mL, 500-mL bag (concentration 1.8 mg/mL, NDC 88890-0333-01), from lot 170711-005 (Exp. 10/9/17); and
- morphine 50 mg in 0.9% sodium chloride 5 mL PCA, 50-mL cartridge (concentration 1 mg/mL, NDC 88887-6795-01), from lots 170627-012 (9/25/17) and 170629-019 (9/27/17).
SSM Health issued the recall August 10, 2017. On December 28, 2017, the FDA designated it Class II, indicating use of the drugs could cause temporary or reversible adverse effects with a remote probability of serious adverse consequences.
The fentanyl compounded formulations are used for regional anesthesia and pain relief. Amiodarone in dextrose 5% can prevent and treat ventricular fibrillation, atrial fibrillation, and related heart issues. Morphine in sodium chloride is used in the treatment of patients with severe pain.
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