Recall: D-0927-2018

Class II - Potentially Harmful

Class IIClassification

2018-06-28Initiated

TerminatedStatus

LUPIN SOMERSETFirm

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

Subpotent Drug and Failed Content Uniformity.

Distribution

Nationwide within the US

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.