FDA-Drug2019-01-09Class II
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.
LUPIN SOMERSET
Hazard
Subpotent Drug: Expansion of June 2018 recall of lots S700065 and S700619 due to below specification results for assay.
Sold states
Nationwide in the USA and Puerto Rico.
Affected count
23,460 bottles
Manufactured in
400 Campus Dr, N/A, Somerset, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0346-2019Don't want to check this manually?
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