Phenazopyridine Hydrochloride Tablets, USP, 100 mg, 100 count bottles, Rx only, Manufactured for: Nationwide Laboratories LLC, Iselin, New Jersey 08830, NDC 42937-701-10.
Reported: December 7, 2016 Initiated: October 28, 2016 #D-0167-2017
Product Description
Phenazopyridine Hydrochloride Tablets, USP, 100 mg, 100 count bottles, Rx only, Manufactured for: Nationwide Laboratories LLC, Iselin, New Jersey 08830, NDC 42937-701-10.
Reason for Recall
CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.
Details
- Recalling Firm
- Nationwide Laboratories, LLC
- Units Affected
- 6,333,669 tablets
- Distribution
- Nationwide in USA and Puerto Rico
- Location
- Iselin, NJ
Frequently Asked Questions
What product was recalled? ▼
Phenazopyridine Hydrochloride Tablets, USP, 100 mg, 100 count bottles, Rx only, Manufactured for: Nationwide Laboratories LLC, Iselin, New Jersey 08830, NDC 42937-701-10.. Recalled by Nationwide Laboratories, LLC. Units affected: 6,333,669 tablets.
Why was this product recalled? ▼
CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 7, 2016. Severity: Moderate. Recall number: D-0167-2017.
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