Home / Recalls / Daiichi Sankyo Pharma Development / D-1504-2014

D-1504-2014 Class II Terminated

Recalled by Daiichi Sankyo Pharma Development — Edison, NJ

Recall Details

Product Type
Drugs
Report Date
August 6, 2014
Initiation Date
July 12, 2014
Termination Date
March 16, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity

Product Description

Tribenzor Tablets (olmesartan medoxomil/amlodipine/hydrochlorothiazide), 40 mg/5 mg*/25 mg 30 count bottles, Rx Only Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-116-30

Reason for Recall

Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping

Distribution Pattern

Nationwide

Code Information

Lot #211836 Exp - 11/30/2016

Other recalls by Daiichi Sankyo Pharma Development

  • D-1507-2014 Class II — Benicar HCT Tablets (olmesartan medoxomil/hydrochlorothiazide) 40 mg/12.5 mg, 30 (July 12, 2014)
  • D-1506-2014 Class II — Benicar Tablets (olmesartan medoxomil) 40 mg, 30 and 90 count, Rx Only Manufactu (July 12, 2014)
  • D-1508-2014 Class II — Benicar HCT Tablets (olmesartan medoxomil/hydrochlorothiazide) 40 mg/25 mg, 30 a (July 12, 2014)
  • D-1502-2014 Class II — Benicar Tablets (olmesartan medoxomil) 20 mg, 30 and 90 count, Rx Only Manufactu (July 12, 2014)
  • D-1503-2014 Class II — Benicar HCT Tablets (olmesartan medoxomil, hydrochlorothiazide) 20 mg/12.5 mg, 3 (July 12, 2014)
  • D-1501-2014 Class II — Azor Tablets (amlodipine and olmesartan medoxomil) 10 mg*/40 mg, 30 count bottle (July 12, 2014)
  • D-1505-2014 Class II — Welchol Tablets (colesevelam HCl) 625 mg, 180 count bottles, Rx Only, Manufactur (July 12, 2014)