Drug product
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
D-1030-2016
Product summary
- Event
- Event 74194
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2839 bottles
- Official record key
drug-enforcement:D-1030-2016
Official wording
Reason: Failed Dissolution Specifications
Code information: BZP0093A, BZP0094A, BZP0095A, BZP0096A, BZP0097A, Exp 02/2017
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications