FDAFDA · Food and drugs·Recall number D-0167-2017
Phenazopyridine Hydrochloride Tablets, USP, 100 mg, 100 count bottles, Rx only, Manufactured for: Nationwide Laboratories LLC, Iselin, New Jersey 08830, NDC 42937-701-10.
Published December 7, 2016 · Recall initiated: October 28, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Nationwide Laboratories, LLC
- Distributor
- Nationwide in USA and Puerto Rico
- Lot
- Lot #: 28161501, Exp 03/17; 28161502, 28161503, Exp 08/17; 28161601, 28161602, Exp 01/18
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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