Multi-event July 2015 FDA Recall Drug by Mutual Pharmaceutical Company, Inc.

This Multi-event Class III drug recall was voluntarily initiated by Mutual Pharmaceutical Company, Inc. on July 16, 2015 for the product Drug. The FDA reported the reason for recall as chemical contamination; benzophenone leached from the product label varnish. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-1425-2015 TERMINATED D-1424-2015 TERMINATED D-1423-2015 TERMINATED D-1420-2015 TERMINATED D-1422-2015 TERMINATED D-1421-2015 TERMINATED

Recall Number: D-1425-2015

Reason for Recall
Chemical Contamination; benzophenone leached from the product label varnish
Initiated
07-16-2015
Reported
09-16-2015
Quantity
10,080 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71836
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.
Mutual Pharmaceutical Company, 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.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-13-2016
Product Description About Product Description
Full technical description of the product.
Imipramine HCl Tablets, USP, 50 mg, 100 count bottles, Mfd By: Mutual Pharmaceutical Co., Inc., Philadelphia, PA --- NDC 54738-914-01

Batch or Lot Expiration Information

Lot# lots# 6671901, exp 12/16, 6679901, exp 2/17, 6694201, exp 5/17, 6697901, exp 6/17 and 6704201, exp 7/17

Recall Number: D-1424-2015

Reason for Recall
Chemical Contamination; benzophenone leached from the product label varnish
Initiated
07-16-2015
Reported
09-16-2015
Quantity
14,112 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71836
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.
Mutual Pharmaceutical Company, 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.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-13-2016
Product Description About Product Description
Full technical description of the product.
Imipramine HCl Tablets, USP, 25 mg, 100 count bottles, Mfd By: Mutual Pharmaceutical Co., Inc., Philadelphia, PA --- NDC 54738-913-01

Batch or Lot Expiration Information

Lot# s: 6655001, exp 8/16, 6679801, exp 2/17, 6690302, exp 4/17 and 6706001, exp 7/17

Recall Number: D-1423-2015

Reason for Recall
Chemical Contamination; benzophenone leached from the product label varnish
Initiated
07-16-2015
Reported
09-16-2015
Quantity
5472 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71836
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.
Mutual Pharmaceutical Company, 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.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-13-2016
Product Description About Product Description
Full technical description of the product.
Imipramine HCl Tablets, USP, 10 mg, 100 count bottles, Rx only, Mfd By: Mutual Pharmaceutical Co. Inc., Philadelphia, PA --- NDC 54738-912-01

Batch or Lot Expiration Information

Lot# s 6671801, exp 12/16 and 6706401, exp 7/17

Recall Number: D-1420-2015

Reason for Recall
Chemical Contamination; benzophenone leached from the product label varnish
Initiated
07-16-2015
Reported
09-16-2015
Quantity
25,272 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71836
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.
Mutual Pharmaceutical Company, 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.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-13-2016
Product Description About Product Description
Full technical description of the product.
Felodipine Extended-Release Tablets, 2.5 mg, 100 count bottles, Rx only, Mutual Pharmaceutical Co. Inc., Philadelphia, PA --- NDC 53489-368-01

Batch or Lot Expiration Information

Lot# s: 6669101 & 6669201, exp 12/15 and 6708201 & 6708301, exp 8/16

Recall Number: D-1422-2015

Reason for Recall
Chemical Contamination; benzophenone leached from the product label varnish
Initiated
07-16-2015
Reported
09-16-2015
Quantity
63,975 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71836
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.
Mutual Pharmaceutical Company, 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.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-13-2016
Product Description About Product Description
Full technical description of the product.
Felodipine Extended-Release Tablets, 10 mg, 100 count bottles, Rx only, Mutual Pharmaceutical Co Inc., Philadelphia, PA --- NDC 53489-370-01

Batch or Lot Expiration Information

Lot# s: 6667301 & 6667401, exp 11/15 and 6699201, exp 6/16

Recall Number: D-1421-2015

Reason for Recall
Chemical Contamination; benzophenone leached from the product label varnish
Initiated
07-16-2015
Reported
09-16-2015
Quantity
97,859 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71836
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.
Mutual Pharmaceutical Company, 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.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-13-2016
Product Description About Product Description
Full technical description of the product.
Felodipine Extended-Release Tablets, 5 mg, 100 count bottles, Rx only, Mutual Pharmaceutical Co. Inc., Philadelphia, PA --- NDC 53489-369-01

Batch or Lot Expiration Information

Lot# s: 6662801 & 6662901, exp 10/15, 6689601, exp 4/16, 6689701, exp 5/16 and 6708401, 8/16