Drug recall D-0927-2018

Class II Terminated reported Jul 18, 2018

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.

Lots and codes

Lot#: S700065, Exp. 02/2019; 700619, Exp. 08/2019

Recall details

Recalling firm
LUPIN SOMERSET, Somerset, NJ
Quantity
3456 cartons
Distribution
Nationwide within the US
Type
Voluntary: Firm initiated
Recall initiated
June 28, 2018
Terminated
March 6, 2023

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