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, UPC 343386-450-114, NDC 43386-450-11

FDA recall notice · announced July 18, 2018 · Lupin Somerset

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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, UPC 343386-450-114, NDC 43386-450-11

Reason for recall

Subpotent Drug and Failed Content Uniformity.

Notes

Distribution: Nationwide within the US
Lot/code information: Lot#: S700065, Exp. 02/2019; 700619, Exp. 08/2019
Quantity: 3456 cartons
Status: Terminated
Products in this recall event:
- 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, U (D-0927-2018)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.