March 2019 FDA Recall Drug by Petra Hygienic Systems Int Ltd
D-0994-2019 - Does Not Meet Monograph

This Class III drug recall was voluntarily initiated by Petra Hygienic Systems Int Ltd on March 4, 2019 for the product Drug. The FDA reported the reason for recall as does not meet monograph. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0994-2019

Reason for Recall
Does Not Meet Monograph: product contains, triclosan, an ingredient that can no longer be contained in over-the-counter consumer antiseptic/antibacterial wash products.
Initiated
03-04-2019
Reported
03-13-2019
Quantity
58 cases

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82283
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.
Petra Hygienic Systems Int Ltd
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 in the USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-10-2020
Product Description About Product Description
Full technical description of the product.
ATHLETICARE Anti-Bacterial Hand Soap AC 550 (triclosan), 0.25%, 4 litres/1.1 US Gallon bottles, packaged in 4 x 4 Litres/1.1 US gallons per case, Petra Hygienic Systems, Concord, ON L4K 4RS/ Reno, NV 89511, NDC 42326-550-01, UPC 0 65936 10335 5.

Batch or Lot Expiration Information

Lot# All Lots