Multi-event April 2018 FDA Recall Drug by Mckesson Packaging Services

This Multi-event Class III drug recall was voluntarily initiated by Mckesson Packaging Services on April 23, 2018 for the product Drug. The FDA reported the reason for recall as failed dissolution specifications. high dissolution results were obtained during stability testing.. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0715-2018 TERMINATED D-0716-2018 TERMINATED D-0714-2018 TERMINATED

Recall Number: D-0715-2018

Reason for Recall
Failed Dissolution Specifications. High dissolution results were obtained during stability testing.
Initiated
04-23-2018
Reported
05-02-2018
Quantity
7656 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79936
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Packaging Services
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide with the US
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-13-2020
Product Description About Product Description
Full technical description of the product.
Diltiazem CD (Diltiazem Hydrochloride Extended-Release Capsules, USP) 180 mg, 100-count bottles, Rx Only Mfg. By: Actavis 60 Columbia Rd., Bldg. B Morristown, NJ 07960. NDC 63739-284-10

Batch or Lot Expiration Information

Lot# : 0114214, Exp. 09/2018

Recall Number: D-0716-2018

Reason for Recall
Failed Dissolution Specifications. High dissolution results were obtained during stability testing.
Initiated
04-23-2018
Reported
05-02-2018
Quantity
2966 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79936
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Packaging Services
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide with the US
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-13-2020
Product Description About Product Description
Full technical description of the product.
Diltiazem HCl Extended-Release Capsules, USP 240 mg, 100-count bottles, Rx Only, Mfg. By: Par Pharmaceutical One Ram Ridge Rd Chestnut Ridge, NY 10977. NDC: 63739-016-10

Batch or Lot Expiration Information

Lot# : 0115087, Exp. 12/2018

Recall Number: D-0714-2018

Reason for Recall
Failed Dissolution Specifications. High dissolution results were obtained during stability testing.
Initiated
04-23-2018
Reported
05-02-2018
Quantity
4266 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79936
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Packaging Services
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide with the US
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-13-2020
Product Description About Product Description
Full technical description of the product.
Diltiazem HCl Extended-Release Capsules, USP 120 mg, 100-count bottles, Rx only, Mfg. By: Par Pharmaceutical One Ram Ridge Rd Chestnut Ridge, NY 10977. NDC: 63739-014-10

Batch or Lot Expiration Information

Lot# : 0115086, Exp. 12/2018