Multi-event July 2014 FDA Recall Drug by Gyma Laboratories Of Amer,inc

This Multi-event Class II drug recall was voluntarily initiated by Gyma Laboratories Of Amer,inc on July 9, 2014 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0024-2015 TERMINATED D-0023-2015 TERMINATED D-0022-2015 TERMINATED D-0021-2015 TERMINATED

Recall Number: D-0024-2015

Reason for Recall
cGMP Deviations: GYMA laboratories Inc. has recalled multiple Active Pharmaceutical Ingredients manufactured in Italy upon receipt of a Rapid Alert Notification issued by The Italian Medicines Agency due to lack of good manufacturing practices.
Initiated
07-09-2014
Reported
10-22-2014
Quantity
97 Kg

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
69243
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.
Gyma Laboratories Of Amer,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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-04-2018
Product Description About Product Description
Full technical description of the product.
Clonidine HCL, 97 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines Preparation, Made in Italy, NDC 012660-0002

Batch or Lot Expiration Information

Lot# Lot Numbers: 167219, 163367, 167220, 167221, Exp 03/2017

Recall Number: D-0023-2015

Reason for Recall
cGMP Deviations: GYMA laboratories Inc. has recalled multiple Active Pharmaceutical Ingredients manufactured in Italy upon receipt of a Rapid Alert Notification issued by The Italian Medicines Agency due to lack of good manufacturing practices.
Initiated
07-09-2014
Reported
10-22-2014
Quantity
55.8 Kg

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
69243
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.
Gyma Laboratories Of Amer,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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-04-2018
Product Description About Product Description
Full technical description of the product.
Clonidine Base Micronized, 55.8 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines Preparation, Made in Italy, NDC 12660-0503-01

Batch or Lot Expiration Information

Lot# Lot Numbers: 166247, 166248, Exp 10/2016

Recall Number: D-0022-2015

Reason for Recall
cGMP Deviations: GYMA laboratories Inc. has recalled multiple Active Pharmaceutical Ingredients manufactured in Italy upon receipt of a Rapid Alert Notification issued by The Italian Medicines Agency due to lack of good manufacturing practices.
Initiated
07-09-2014
Reported
10-22-2014
Quantity
1 Kg

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
69243
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.
Gyma Laboratories Of Amer,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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-04-2018
Product Description About Product Description
Full technical description of the product.
Propranolol HCl, NET WT 1 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines Preparation, Made in Italy, NDC 012660-0004

Batch or Lot Expiration Information

Lot# Lot Number: 154919, Exp 11/2014

Recall Number: D-0021-2015

Reason for Recall
cGMP Deviations: GYMA laboratories Inc. has recalled multiple Active Pharmaceutical Ingredients manufactured in Italy upon receipt of a Rapid Alert Notification issued by The Italian Medicines Agency due to lack of good manufacturing practices.
Initiated
07-09-2014
Reported
10-22-2014
Quantity
10 Kg

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
69243
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.
Gyma Laboratories Of Amer,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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-04-2018
Product Description About Product Description
Full technical description of the product.
Dipyridamole API, NET WT 10 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines Preparation, Made in Italy, NDC 012660-0084

Batch or Lot Expiration Information

Lot# Lot Number: 161600, Exp 03/2016