Multi-event May 2016 FDA Recall Drug by Profarma Distributors Llc

This Multi-event Class II drug recall was voluntarily initiated by Profarma Distributors Llc on May 11, 2016 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-1040-2016 TERMINATED D-1039-2016 TERMINATED D-1043-2016 TERMINATED D-1042-2016 TERMINATED D-1041-2016 TERMINATED

Recall Number: D-1040-2016

Reason for Recall
CGMP Deviations
Initiated
05-11-2016
Reported
06-29-2016
Quantity
31 boxes ( 372 capsules)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74135
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.
Profarma Distributors 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
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-24-2017
Product Description About Product Description
Full technical description of the product.
tabcin NOCHE; Capsules,12-count box, UPC 501008485033

Batch or Lot Expiration Information

Lot# X223FS; Exp. 11/17

Recall Number: D-1039-2016

Reason for Recall
CGMP Deviations
Initiated
05-11-2016
Reported
06-29-2016
Quantity
42 boxes (504 capsules)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74135
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.
Profarma Distributors 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
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-24-2017
Product Description About Product Description
Full technical description of the product.
tabcin ACTIVE M.R. Capsules, 12-count box , UPC 7501008485057

Batch or Lot Expiration Information

Lot# 224TS; Exp. 02/17

Recall Number: D-1043-2016

Reason for Recall
CGMP Deviations
Initiated
05-11-2016
Reported
06-29-2016
Quantity
79 boxes (79 tubes)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74135
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.
Profarma Distributors 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
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-24-2017
Product Description About Product Description
Full technical description of the product.
1% Clotrimazol cream, 30 mg tube, UPC 501318644335

Batch or Lot Expiration Information

Lot# GRU1390; Exp. 08/17

Recall Number: D-1042-2016

Reason for Recall
CGMP Deviations
Initiated
05-11-2016
Reported
06-29-2016
Quantity
254 boxes (254 tablets)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74135
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.
Profarma Distributors 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
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-24-2017
Product Description About Product Description
Full technical description of the product.
VERMOX Tablets 500 mg, 1-count box, UPC 501109900596

Batch or Lot Expiration Information

Lot# UJE 040; Exp. 02/17

Recall Number: D-1041-2016

Reason for Recall
CGMP Deviations
Initiated
05-11-2016
Reported
06-29-2016
Quantity
163 boxes (978 tablets)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74135
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.
Profarma Distributors 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
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-24-2017
Product Description About Product Description
Full technical description of the product.
VERMOX Tablets 100 mg; 6-count box, UPC 7501109900619

Batch or Lot Expiration Information

Lot# UPE187; Exp. 08/17