D-1030-2016 Class II Terminated
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