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

This Multi-event Class II 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 microbial contamination of non-sterile product. The product was distributed in Within the United States and Puerto Rico and the recall is currently terminated.

Reported Recall Events

D-0811-2018 TERMINATED D-0812-2018 TERMINATED D-0814-2018 TERMINATED D-0813-2018 TERMINATED

Recall Number: D-0811-2018

Reason for Recall
Microbial Contamination of Non-sterile Product
Initiated
05-04-2018
Reported
05-23-2018
Quantity
3,477 plastic bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80042
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.
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.
Within the United States and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-26-2019
Product Description About Product Description
Full technical description of the product.
B Prox 10 Anti-blemish Wash, (Benzoyl peroxide 10%), 200 mL bottles, Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA

Batch or Lot Expiration Information

Lot# Lot: # ET507-0, Exp. 5/27/2019; GU894-8, Exp. 7/20/2010

Recall Number: D-0812-2018

Reason for Recall
GMP Deviations
Initiated
05-04-2018
Reported
05-23-2018
Quantity
2,156 tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80042
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.
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.
Within the United States and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-26-2019
Product Description About Product Description
Full technical description of the product.
Solar Defense Sheer Sunscreen Broad Spectrum SPF50 (Octinoxate 7.5%, Zinc Oxide 10.5%), 2.5 FL OZ. 74 mL, Distributed by: BeautyRx LLC, NY, NY 10128

Batch or Lot Expiration Information

Lot# : KU455-2, Exp. 11/09/2020; KU455-6, Exp.11/26/2020

Recall Number: D-0814-2018

Reason for Recall
GMP Deviations
Initiated
05-04-2018
Reported
05-23-2018
Quantity
14,491 tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80042
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.
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.
Within the United States and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-26-2019
Product Description About Product Description
Full technical description of the product.
MD Complete Clarifying Cleanser (Salicylic Acid 2.0%), 3 fl oz, (88.7mL), MD Professional LLC, Minneapolis, MN

Batch or Lot Expiration Information

Lot# : KU503-6, KU393-6, Exp. 12/28/2020

Recall Number: D-0813-2018

Reason for Recall
GMP Deviations
Initiated
05-04-2018
Reported
05-23-2018
Quantity
4,815 tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80042
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.
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.
Within the United States and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-26-2019
Product Description About Product Description
Full technical description of the product.
Naturmetic SPF 50 Sunscreen (Octinoxate 7.5%, Zinc Oxide 10.5%), 2.0 fl oz/60mL bottles, Fortis BioPharma, Magnolia, TX 77354.

Batch or Lot Expiration Information

Lot# : KU455-4, Exp.10/30/2020