Class II · Moderate risk
Phenazopyridine Hydrochloride Tablets
CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.
Salsalate Tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
What was recalled
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.
Affected NDCs
42937-0703-10
42937-0703-18
42937-0703-20
Compare with the code on your package — it is the most precise check available.
- Recalling firm
- Nationwide Laboratories, LLC
- NDC code
- 42937-703-18
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0165-2017 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other recalls by Nationwide Laboratories, LLC
All 2016 recalls
Class II · Moderate risk
Phenazopyridine Hydrochloride Tablets
CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.
Class II · Moderate risk
Salsalate Tablets
CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.
Other wrong potency / content recalls from 2016
All wrong potency / content recalls
Class III · Low risk
Aripiprazole Tablets
Superpotent Drug; out of specification results for assay (manufacturer)
Class II · Moderate risk
Amoxicillin for Oral Suspension USP
Subpotency: due to a low, out of specification test result for assay during stability testing.
Class III · Low risk
Aripiprazole Tablets
Superpotent Drug: Product may not meet specifications throughout shelf life.
Class III · Low risk
Donepezil Hydrochloride Tablets
Subpotent Drug: out of specification results for assay test.
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