Multi-event August 2018 FDA Recall Drug by Mylan Pharmaceuticals Inc.

This Multi-event Class III drug recall was voluntarily initiated by Mylan Pharmaceuticals Inc. on August 7, 2018 for the product Drug. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-1187-2018 TERMINATED D-1186-2018 TERMINATED

Recall Number: D-1187-2018

Reason for Recall
Failed Impurities/Degradation Specifications: Out of specification test results obtained during routine stability testing for related compound.
Initiated
08-07-2018
Reported
09-19-2018
Quantity
656 500-count bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80782
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.
Mylan Pharmaceuticals Inc.
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.
Distributed Nationwide in the US
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-14-2019
Product Description About Product Description
Full technical description of the product.
Diltiazem HCl Extended-Release Capsules, USP 120 mg 500-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505. NDC 0378-5220-05

Batch or Lot Expiration Information

Batch# Batch code # 3093163, expiration date 04/2019

Recall Number: D-1186-2018

Reason for Recall
Failed Impurities/Degradation Specifications: Out of specification test results obtained during routine stability testing for related compound.
Initiated
08-07-2018
Reported
09-19-2018
Quantity
11,799 bottles of 100

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80782
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.
Mylan Pharmaceuticals Inc.
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.
Distributed Nationwide in the US
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-14-2019
Product Description About Product Description
Full technical description of the product.
Diltiazem HCl Extended-Release Capsules, USP 120 mg 100-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505. NDC 0378-5220-01

Batch or Lot Expiration Information

Batch# Batch code # 3093163, expiration date 04/2019