Phenazopyridine Hydrochloride Tablets recalled over manufacturing violations
- Recall date
- October 28, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Nationwide Laboratories, LLC recalls Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles, Rx only, Manufactured for: Nationwide Laboratori…
- Recall number
- D-0168-2017
- FDA classification
- Class II
- Brand / firm
- Nationwide Laboratories, LLC
- Sold / distributed
- Nationwide in USA and Puerto Rico
Why it was recalled
CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles, Rx only, Manufactured for: Nationwide Laboratories LLC, Iselin, New Jersey 08830, NDC 42937-702-10.
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