Nostrum Laboratories, Inc. recalls Nitrofurantoin Oral Suspension, USP, 25 mg/5 mL, FOR ORAL USE ONLY, URINARY TRACT ANTIBACTERIAL, Rx Only , 240 mL bottl…
- Recall date
- May 23, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-1030-2016
- FDA classification
- Class II
- Brand / firm
- Nostrum Laboratories, Inc.
- Sold / distributed
- Nationwide
Why it was recalled
Failed Dissolution Specifications
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What 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
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