Multi-event April 2018 FDA Recall Drug by Mylan Pharmaceuticals Inc.
This Multi-event Class II drug recall was voluntarily initiated by Mylan Pharmaceuticals Inc. on April 24, 2018 for the product Drug. The FDA reported the reason for recall as cgmp deviations; cleaning process for equipment used to manufacture the specified batches was not followed according to procedure. The product was distributed in Product was distributed throughout United States and the recall is currently terminated.
Reported Recall Events
Recall Number: D-0819-2018
cGMP Deviations; cleaning process for equipment used to manufacture the specified batches was not followed according to procedure
04-24-2018
05-23-2018
25,488 bottles
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
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.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was distributed throughout United States
06-20-2019
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Amlodipine and Benazapril HCL Capsules, USP, 5 mg/10 mg, 100 count bottles, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-6896-01
Batch or Lot Expiration Information
Lot# Lot Numbers# 3083005, 3083006, 3086121, and 3086122, exp Jan 2019
Recall Number: D-0820-2018
cGMP Deviations; cleaning processes for equipment used to manufacture the specified batches was not followed according to procedure
04-24-2018
05-23-2018
12,924 bottles
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
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.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was distributed throughout United States
06-20-2019
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Amlodipine and Benazapril HCL Capsules, USP, 5 mg/40 mg, 100 count bottles, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-6899-01
Batch or Lot Expiration Information
Lot# Lot Numbers# 3083008 and 3086124, exp Jan 2019
