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Recall Observatory FDA recall evidence

Drug 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.

D-0165-2017

October 28, 2016

Class II

Product summary

Firm
Nationwide Laboratories, LLC
Event
Event 75655
Status
Terminated
Classification
Class II
Quantity
2,882,661 tablets
Official record key
drug-enforcement:D-0165-2017

Official wording

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

Code information: 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

Distribution pattern: Nationwide in USA and Puerto Rico

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations