D-0994-2019 Class III Terminated
FDA drug recall D-0994-2019 was initiated by Petra Hygienic Systems Int Ltd on March 4, 2019 and is designated Class III. 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. The recall status is terminated (terminated December 10, 2020). Affected quantity: 58 cases.
Recall Details
- Product Type
- Drugs
- Report Date
- March 13, 2019
- Initiation Date
- March 4, 2019
- Termination Date
- December 10, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 58 cases
Product Description
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.
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.
Distribution Pattern
Nationwide in the USA.
Code Information
All Lots