Multi-event May 2018 FDA Recall Drug by Milbar Laboratories, Inc.

This Multi-event Class III drug recall was voluntarily initiated by Milbar Laboratories, Inc. on May 4, 2018 for the product Drug. The FDA reported the reason for recall as subpotent. The product was distributed in Product was distributed to physicians and internet sales throughout the United States and Hong Kong, Panama, UK, China, Jordan, Qatar, Kuwait, and Central America. and the recall is currently terminated.

Reported Recall Events

D-0832-2018 TERMINATED D-0833-2018 TERMINATED

Recall Number: D-0832-2018

Reason for Recall
Subpotent
Initiated
05-04-2018
Reported
05-30-2018
Quantity
952 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80045
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.
Milbar Laboratories, 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.
Product was distributed to physicians and internet sales throughout the United States and Hong Kong, Panama, UK, China, Jordan, Qatar, Kuwait, and Central America.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-18-2019
Product Description About Product Description
Full technical description of the product.
T Shampoo For Hair and Body, Solution Coal Tar 3% (0.6% coal tar), 300 ml/10.1 fl. oz. bottles, Dermatologic Cosmetic Laboratories, East Haven, CT

Batch or Lot Expiration Information

Lot# MT390-8, expiration date 12/01/2020 GU925-4, expiration date 07/05/2020

Recall Number: D-0833-2018

Reason for Recall
Subpotent
Initiated
05-04-2018
Reported
05-30-2018
Quantity
1,348 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80045
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.
Milbar Laboratories, 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.
Product was distributed to physicians and internet sales throughout the United States and Hong Kong, Panama, UK, China, Jordan, Qatar, Kuwait, and Central America.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-18-2019
Product Description About Product Description
Full technical description of the product.
Zoma Shampoo, Zinc Pyrithione 1.92%, 300 ml/10.01 fl. oz. bottles, Dermatologic Cosmetic Laboratories, East Haven, CT

Batch or Lot Expiration Information

Lot# HT659-6, expiration date 08/11/2019 LT168-7, expiration date 11/10/2019