Multi-event December 2012 FDA Recall Drug by Amedra Pharmaceuticals Llc

This Multi-event Class II drug recall was voluntarily initiated by Amedra Pharmaceuticals Llc on December 4, 2012 for the product Drug. The FDA reported the reason for recall as failed dissolution specifications. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-171-2013 TERMINATED D-173-2013 TERMINATED D-172-2013 TERMINATED

Recall Number: D-171-2013

Reason for Recall
Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life.
Initiated
12-04-2012
Reported
03-06-2013
Quantity
1,176 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
63926
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.
Amedra 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.
Nationwide and Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-21-2014
Product Description About Product Description
Full technical description of the product.
Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by Catalent Pharma Solutions for CorePharma, LLC Middlesex, NJ 08846 NDC 64720-327-09

Batch or Lot Expiration Information

Lot# Lot 238316, exp 01/31/2014

Recall Number: D-173-2013

Reason for Recall
Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life.
Initiated
12-04-2012
Reported
03-06-2013
Quantity
10,968 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
63926
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.
Amedra 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.
Nationwide and Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-21-2014
Product Description About Product Description
Full technical description of the product.
Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by Catalent Pharma Solutions for CorePharma, LLC Middlesex, NJ 08846 NDC 64720-329-09

Batch or Lot Expiration Information

Lot# Lot 220843, exp 11/30/2013

Recall Number: D-172-2013

Reason for Recall
Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life.
Initiated
12-04-2012
Reported
03-06-2013
Quantity
12,948 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
63926
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.
Amedra 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.
Nationwide and Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-21-2014
Product Description About Product Description
Full technical description of the product.
Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by Catalent Pharma Solutions for CorePharma, LLC Middlesex, NJ 08846 NDC 64720-328-09

Batch or Lot Expiration Information

Lot# Lot 220839, exp 11/30/2013