Reported Dec 7, 2016 · Terminated
Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles, Rx only, Manufactured for: Nationwide…
Nationwide Laboratories, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Nationwide Laboratories, LLC · 33 Wood Ave S Ste 600 · Iselin, NJ · 08830-2717
Is this the product you have?
- Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles, Rx only
- Manufactured forNationwide Laboratories LLC, Iselin, New Jersey 08830, NDC 42937-702-10
- Lot codes and dates
Lot #: 2818150128181502Exp 03/172818150328181504Exp 08/172818150528181506Exp 09/1728181601Exp 01/18
- Amount recalled
- 5,786,653 tablets
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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