D-1030-2016 Class II Terminated
FDA drug recall D-1030-2016 was initiated by Nostrum Laboratories, Inc. on May 23, 2016 and is designated Class II. Reason for recall: Failed Dissolution Specifications The recall status is terminated (terminated Apr 28, 2017). Affected quantity: 2839 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Jun 22, 2016
- Initiation Date
- May 23, 2016
- Termination Date
- Apr 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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1030-2016
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026