July 20, 2018
Lupin Somerset is voluntarily pulling 2 lots of nitrofurantoin oral suspension, USP, 25 mg/5 mL (NDC 43386-450-11), because the drug is subpotent, according to the July 18, 2018, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects 230-mL bottles manufactured for Lupin Pharmaceuticals by Novel Laboratories from lots S700065 (Exp. 2/19) and 700619 (Exp. 8/19). Bottles from the lots were distributed within the United States.
Lupin initiated the recall June 28, 2018. At press time, the FDA had not yet issued a recall classification.
Nitrofurantoin oral suspension is a prescription antibiotic used to treat or prevent urinary tract infections.
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