Oral Antibiotic Recalled

January 11, 2019

Lupin Somerset is recalling nearly 24,000 bottles of nitrofurantoin oral suspension, USP, 25 mg/5mL, because the drug is subpotent, according to the January 9, 2019, US Food and Drug Administration (FDA) Enforcement Report.

The recalled affects 230-mL bottles (NDC 43386-450-11) manufactured for Lupin Pharmaceuticals by Novel Laboratories. Recalled are bottles distributed across the United States and in Puerto Rico from lots S700038, S700044, S700059, and S700065 (Exp. 2/28/19); S700410 and S700427 (Exp. 6/30/19); S700617 and S700619 (Exp. 8/31/19); S700813, S700815, and S700869 (Exp. 10/31/19); S700871 and S700873 (Exp. 11/30/19); and S700875 and S701073 (Exp. 12/31/19).

Lupin Somerset initiated the voluntary recall December 21, 2018. On December 31, 2018, the FDA designated the recall Class II, signaling use of the product could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.

Nitrofurantoin oral suspension is a prescription antibiotic used to treat or prevent bladder, kidney, and urinary tract infections.

Jolynn Tumolo

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