Multi-event June 2018 FDA Recall Drug by Aidarex Pharmaceuticals Llc

This Multi-event Class III drug recall was voluntarily initiated by Aidarex Pharmaceuticals Llc on June 27, 2018 for the product Drug. The FDA reported the reason for recall as out-of-specification results for the enalapril diketopiperazine degradation product during commercial stability.. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0991-2018 TERMINATED D-0992-2018 TERMINATED D-0990-2018 TERMINATED

Recall Number: D-0991-2018

Reason for Recall
Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.
Initiated
06-27-2018
Reported
08-01-2018
Quantity
61, 90-count bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80397
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.
Aidarex Pharmaceuticals LLC
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 USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-04-2019
Product Description About Product Description
Full technical description of the product.
Enalapril Maleate, USP 5MG, 90-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0693-90

Batch or Lot Expiration Information

Lot# Lots: 51904-1, EXP: 01/31/2018; 51904-4, 52885-1, EXP: 03/31/2018; 52885-3, EXP: 04/30/2018; 52885-4,EXP: 05/28/2018; 53840-2,EXP: 5/28/2018; 53840-3, EXP:6/30/2018; 53840-4, EXP:8/31/2018; 56665-1, EXP: 01/31/2019; 58596-1, EXP: 05/28/2019.

Recall Number: D-0992-2018

Reason for Recall
Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.
Initiated
06-27-2018
Reported
08-01-2018
Quantity
25, 30-count bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80397
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.
Aidarex Pharmaceuticals LLC
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 USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-04-2019
Product Description About Product Description
Full technical description of the product.
Enalapril Maleate, USP 5MG, 30-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0693-30

Batch or Lot Expiration Information

Lot# Lots: 51904-2, EXP: 01/31/2018; 51904-3, EXP: 02/28/2018; 51904-5, EXP: 03/31/2018; 52885-2, EXP: 03/31/2018, 53840-1, EXP: 5/28/2018.

Recall Number: D-0990-2018

Reason for Recall
Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.
Initiated
06-27-2018
Reported
08-01-2018
Quantity
11, 90-count bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80397
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.
Aidarex Pharmaceuticals LLC
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 USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-04-2019
Product Description About Product Description
Full technical description of the product.
Enalapril Maleate, USP 2.5MG, 90-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0977-90

Batch or Lot Expiration Information

Lot# Lots: 56698-1, EXP 1/31/2019; 56698-2, EXP 4/30/2019