D-1030-2016 Class II Terminated

Recalled by Nostrum Laboratories, Inc. — Bryan, OH

Recall Details

Product Type
Drugs
Report Date
June 22, 2016
Initiation Date
May 23, 2016
Termination Date
April 28, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2839 bottles

Product Description

Nitrofurantoin Oral Suspension, USP, 25 mg/5 mL, FOR ORAL USE ONLY, URINARY TRACT ANTIBACTERIAL, Rx Only , 240 mL bottle, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Mfg. by: Sun Pharmaceutical Industries, Inc., Bryan, Ohio 43506, NDC 57664-239-32

Reason for Recall

Failed Dissolution Specifications

Distribution Pattern

Nationwide

Code Information

BZP0093A, BZP0094A, BZP0095A, BZP0096A, BZP0097A, Exp 02/2017