Home / Recalls / Daiichi Sankyo Pharma Development / D-1508-2014

D-1508-2014 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

Benicar HCT Tablets (olmesartan medoxomil/hydrochlorothiazide) 40 mg/25 mg, 30 and 90 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-107-30 and NDC 65597-107-90

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

30 count/Lot #0002108 Exp - 12/31/2016; 90 count/Lot #0002078 Exp - 12/31/2016

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-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-1504-2014 Class II — Tribenzor Tablets (olmesartan medoxomil/amlodipine/hydrochlorothiazide), 40 mg/5 (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)