Home / Recalls / Nationwide Laboratories, LLC / D-0165-2017

D-0165-2017 Class II Terminated

Recalled by Nationwide Laboratories, LLC — Iselin, NJ

Recall Details

Product Type
Drugs
Report Date
December 7, 2016
Initiation Date
October 28, 2016
Termination Date
May 17, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2,882,661 tablets

Product Description

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.

Reason for Recall

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

Distribution Pattern

Nationwide in USA and Puerto Rico

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

Other recalls by Nationwide Laboratories, LLC

  • D-0166-2017 Class II — Salsalate Tablets, USP, 750 mg, packaged in a) 100 count bottles (NDC 42937-704- (October 28, 2016)
  • D-0168-2017 Class II — Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles, Rx only, (October 28, 2016)
  • D-0167-2017 Class II — Phenazopyridine Hydrochloride Tablets, USP, 100 mg, 100 count bottles, Rx only, (October 28, 2016)