Multi-event July 2014 FDA Recall Drug by Daiichi Sankyo Pharma Development

This Multi-event Class II drug recall was voluntarily initiated by Daiichi Sankyo Pharma Development on July 12, 2014 for the product Drug. The FDA reported the reason for recall as temperature abuse; various products were not stored at controlled room temperature as per usp guidelines during shipping.. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-1506-2014 TERMINATED D-1507-2014 TERMINATED D-1508-2014 TERMINATED D-1502-2014 TERMINATED D-1503-2014 TERMINATED D-1504-2014 TERMINATED D-1501-2014 TERMINATED D-1505-2014 TERMINATED

Recall Number: D-1506-2014

Reason for Recall
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping.
Initiated
07-12-2014
Reported
08-06-2014
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
68793
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Daiichi Sankyo Pharma Development
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-16-2015
Product Description About Product Description
Full technical description of the product.
Benicar Tablets (olmesartan medoxomil) 40 mg, 30 and 90 count, Rx Only Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-104-30 and 65597-104-90

Batch or Lot Expiration Information

Lot# 30 count -
Lot# 0002096 Exp - 12/31/2016; 90 count -
Lot# 0002058 Exp -12/31/2016

Recall Number: D-1507-2014

Reason for Recall
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping.
Initiated
07-12-2014
Reported
08-06-2014
Quantity
86 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
68793
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Daiichi Sankyo Pharma Development
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-16-2015
Product Description About Product Description
Full technical description of the product.
Benicar HCT Tablets (olmesartan medoxomil/hydrochlorothiazide) 40 mg/12.5 mg, 30 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-106-30

Batch or Lot Expiration Information

Lot# 0002073 Exp - 12/31/2016

Recall Number: D-1508-2014

Reason for Recall
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping.
Initiated
07-12-2014
Reported
08-06-2014
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
68793
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Daiichi Sankyo Pharma Development
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-16-2015
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

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

Recall Number: D-1502-2014

Reason for Recall
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
Initiated
07-12-2014
Reported
08-06-2014
Quantity
262 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
68793
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Daiichi Sankyo Pharma Development
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-16-2015
Product Description About Product Description
Full technical description of the product.
Benicar Tablets (olmesartan medoxomil) 20 mg, 30 and 90 count, Rx Only Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-103-30 and NDC 65597-103-90

Batch or Lot Expiration Information

Lot# 30 count -
Lot# 0002055 Exp - 11/30/2016; 90 count -
Lot# 0002063 Exp - 12/31/2016

Recall Number: D-1503-2014

Reason for Recall
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
Initiated
07-12-2014
Reported
08-06-2014
Quantity
108 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
68793
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Daiichi Sankyo Pharma Development
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-16-2015
Product Description About Product Description
Full technical description of the product.
Benicar HCT Tablets (olmesartan medoxomil, hydrochlorothiazide) 20 mg/12.5 mg, 30 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-105-30

Batch or Lot Expiration Information

Lot# 0002106 Exp - 11/30/2016

Recall Number: D-1504-2014

Reason for Recall
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
Initiated
07-12-2014
Reported
08-06-2014
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
68793
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Daiichi Sankyo Pharma Development
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-16-2015
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

Lot# 211836 Exp - 11/30/2016

Recall Number: D-1501-2014

Reason for Recall
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
Initiated
07-12-2014
Reported
08-06-2014
Quantity
5 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
68793
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Daiichi Sankyo Pharma Development
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-16-2015
Product Description About Product Description
Full technical description of the product.
Azor Tablets (amlodipine and olmesartan medoxomil) 10 mg*/40 mg, 30 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc. Parsippany, NJ 07054 NDC 65597-113-30

Batch or Lot Expiration Information

Lot# 213655B Exp - 12/31/2017

Recall Number: D-1505-2014

Reason for Recall
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
Initiated
07-12-2014
Reported
08-06-2014
Quantity
68 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
68793
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Daiichi Sankyo Pharma Development
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-16-2015
Product Description About Product Description
Full technical description of the product.
Welchol Tablets (colesevelam HCl) 625 mg, 180 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 ---NDC 65597-701-18

Batch or Lot Expiration Information

Lot# Lot NVWG Exp - 11/30/2016