The Recall Desk

FDA (Drugs) recall action 75655

Nationwide Laboratories, LLC recalled 4 products on 2016-12-07

The FDA (Drugs) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.

Products
4
Announced
2016-12-07
Critical
0
Units
17,517,483

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–4 of 4

  • ModerateFDA (Drugs)··2016-12-07

    Nationwide Laboratories Recalls Phenazopyridine Hydrochloride Tablets Due to Manufacturing Deviations

    Nationwide Laboratories is recalling Phenazopyridine Hydrochloride Tablets due to manufacturing deviations that may result in assay or content uniformity failures.

    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.
    Category
    Distribution
    1 state
  • ModerateFDA (Drugs)··2016-12-07

    Nationwide Laboratories Recalls Salsalate Tablets Due to Manufacturing Deviations

    Nationwide Laboratories is recalling Salsalate Tablets, 750 mg, because they were manufactured under practices that may result in assay or content uniformity failures.

    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.
    Category
    Distribution
    1 state
  • ModerateFDA (Drugs)··2016-12-07

    Nationwide Laboratories Recalls Phenazopyridine Hydrochloride Tablets Due to CGMP Deviations

    Nationwide Laboratories LLC is recalling Phenazopyridine Hydrochloride Tablets, 200 mg, due to manufacturing deviations that may result in assay or content uniformity failures.

    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.
    Category
    Distribution
    1 state
  • ModerateFDA (Drugs)··2016-12-07

    Nationwide Laboratories Recalls Salsalate Tablets Due to Manufacturing Deviations

    Nationwide Laboratories is recalling Salsalate Tablets, USP, 500 mg, because they were manufactured under practices that may result in assay or content uniformity failures.

    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.
    Category
    Distribution
    1 state