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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug

Nationwide Laboratories, LLC: CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.

Agency Publication Date: December 1, 2016
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Affected Products

Product: Salsalate Tablets, USP, 500 mg, packaged in a) 500 count bottles (NDC 42937-703-18); b) 100 count bottles (NDC 42937-703-10); and c) 1000 count bottles (NDC 42937-703-20); Rx only, Manufactured for: Nationwide Laboratories LLC, Iselin, New Jersey 08830.

Lot #: a) 28121501, 28121502, 28121503, 28121504, Exp 03/17; 28121505, Exp 06/17; 28121506, 28121507, Exp 09/17; b) 28121503, 28121504, Exp 03/17; 28121505, Exp 06/17; 28121506, 28121507, Exp 09/17; c) 28121505, Exp 06/17; 28121506, 28121507, Exp 09/17

Product: Salsalate Tablets, USP, 750 mg, packaged in a) 100 count bottles (NDC 42937-704-10); b) 500 count bottles (NDC 42937-704-18); and c) 1000 count bottles (NDC 42937-704-20); Rx only, Manufactured for: Nationwide Laboratories LLC, Iselin, New Jersey 08830.

Lot #: a) 28141502, 28141503, 28141504, 28141505, 28141506, Exp 03/17; 28141507, Exp 09/17; 28141508, 28141510, 28141511, Exp 10/17; b) 28141502, 28141504, 28141506, Exp 03/17; 28141507, Exp 09/17; 28141508, 28141510, 28141511, Exp 10/17; c) 28141501, 28141502, 28141504, 28141506, Exp 03/17; 28141507, Exp 09/17; 28141508, 28141510, 28141511, Exp 10/17

Product: Phenazopyridine Hydrochloride Tablets, USP, 100 mg, 100 count bottles, Rx only, Manufactured for: Nationwide Laboratories LLC, Iselin, New Jersey 08830, NDC 42937-701-10.

Lot #: 28161501, Exp 03/17; 28161502, 28161503, Exp 08/17; 28161601, 28161602, Exp 01/18

Lot Numbers:
28161501
Product: Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles, Rx only, Manufactured for: Nationwide Laboratories LLC, Iselin, New Jersey 08830, NDC 42937-702-10.

Lot #: 28181501, 28181502, Exp 03/17; 28181503, 28181504, Exp 08/17; 28181505, 28181506, Exp 09/17; 28181601, Exp 01/18

Lot Numbers:
28181501

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 75655
Status: Resolved
Manufacturer: Nationwide Laboratories, LLC
Manufactured In: United States
Units Affected: 4 products (2,882,661 tablets; 2,514,500 tablets; 6,333,669 tablets; 5,786,653 tablets)

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.