Home / Recalls / Prinston Pharmaceutical Inc / D-1049-2016

D-1049-2016 Class III Terminated

Recalled by Prinston Pharmaceutical Inc — Cranbury, NJ

Recall Details

Product Type
Drugs
Report Date
June 29, 2016
Initiation Date
May 30, 2016
Termination Date
June 9, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
60 bottles (5 cases)

Product Description

Irbesartan and Hydrochlorothiazide Tablets, USP, 300/12.5 mg, Rx only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd, Xunqiao, Linhai, Zhejiang 317024, China; Distributed by: Solco Healthcare U.S., LLC, Cranbury, NJ 08512, NDC 43547-331-09.

Reason for Recall

Labeling: Incorrect or Missing Lot and/or Exp Date: Incorrect lot number, 327B160012, appears on the case label, the correct lot number, 327B16002 appears on the immediate container.

Distribution Pattern

Nationwide

Code Information

Lot #: 327B16002, Exp 12/17

Other recalls by Prinston Pharmaceutical Inc

  • D-0412-2019 Class II — Irbesartan and Hydrochlorothiazide Tablets, USP 300/12.5 mg Rx Only Manufactured (January 18, 2019)
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  • D-0409-2019 Class II — Irbesartan Tablets 300 mg 90 count Rx only Manufactured by: Zhejiang Huahai (January 18, 2019)
  • D-0413-2019 Class II — Irbesartan and Hydrochlorothiazide Tablets, USP 150/12.5 mg Rx 30 Tablets Only M (January 18, 2019)
  • D-0411-2019 Class II — Irbesartan and Hydrochlorothiazide Tablets, USP 300/12.5 mg Rx Only Manufactured (January 18, 2019)
  • D-0973-2018 Class II — Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 160 MG/12.5 MG Table (July 13, 2018)
  • D-0970-2018 Class II — Solco Healthcare US Valsartan, USP, 160 MG Tablets, 90-count bottles, Rx Only Ma (July 13, 2018)
  • D-0974-2018 Class II — Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 160 MG/25 MG Tablets (July 13, 2018)
  • D-0969-2018 Class II — Solco Healthcare US Valsartan, USP, 80 MG Tablets, 90-count bottle, Rx Only Manu (July 13, 2018)
  • D-0975-2018 Class II — Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 320 MG/12.5 MG Table (July 13, 2018)