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
Reported: June 22, 2016 Initiated: May 23, 2016 #D-1030-2016
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
Details
- Recalling Firm
- Nostrum Laboratories, Inc.
- Units Affected
- 2839 bottles
- Distribution
- Nationwide
- Location
- Bryan, OH
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Nostrum Laboratories, Inc.. Units affected: 2839 bottles.
Why was this product recalled? ▼
Failed Dissolution Specifications
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 22, 2016. Severity: Moderate. Recall number: D-1030-2016.
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