LUPIN SOMERSET recalls Nitrofurantoin Oral Suspension, USP, 25mg/5mL, 230 mL bottle, Rx only, Manufactured by: Novel Laboratories, Inc., Somers
Recalled January 9, 2019 · FDA recall D-0346-2019 · LUPIN SOMERSET
Hazard
Subpotent Drug: Expansion of June 2018 recall of lots S700065 and S700619 due to below specification results for assay. · FDA Class II
Units
23,460 bottles
Sold at
Nationwide in the USA and Puerto Rico.
Description
Subpotent Drug: Expansion of June 2018 recall of lots S700065 and S700619 due to below specification results for assay.
Product
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.
Manufacturer(s)
LUPIN SOMERSET
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →