Nitrofurantoin Oral Suspension, USP, 25mg/5mL, 230 mL bottle, Rx only, Manufactured by: Novel Laboratories, Inc., Somerset, NJ 08873; Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, NDC 43386-450-11.
Check against the official notice below — it lists the full affected range.
Lupin Pharmaceuticals is recalling Nitrofurantoin Oral Suspension, USP, 25mg/5mL in 230 mL bottles manufactured by Novel Laboratories, Inc. The recall affects 23,460 bottles distributed nationwide in the USA and Puerto Rico. The medication is being recalled because it is subpotent, meaning it contains below-specification levels of the active ingredient based on assay results. This is an expansion of a recall that began in June 2018 involving lots S700065 and S700619, and now includes additional lots with various expiration dates ranging from February 2019 through December 2019.
The affected lot numbers are S700038, S700044, S700059, S700065, S700410, S700427, S700617, S700619, S700813, S700815, S700869, S700871, S700873, S700875, and S701073. The source does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Subpotent Drug: Expansion of June 2018 recall of lots S700065 and S700619 due to below specification results for assay.
Reason for recall: Subpotent Drug: Expansion of June 2018 recall of lots S700065 and S700619 due to below specification results for assay. Distribution: Nationwide in the USA and Puerto Rico. Quantity: 23,460 bottles Lot/code info: Lot #: S700038, S700044, S700059, S700065, Exp 28-Feb-19; S700410, S700427, Exp 30-Jun-19; S700617, S700619, Exp 31-Aug-19; S700813, S700815, S700869, Exp 31-Oct-19; S700871, S700873, Exp 30-Nov-19; S700875, S701073, Exp 31-Dec-19.
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.