Why it was recalled
Does Not Meet Monograph: product contains, triclosan, an ingredient that can no longer be contained in over-the-counter consumer antiseptic/antibacterial wash products.
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.
Lot numbers, UPCs & expiration codes
All Lots
Where it was sold
Nationwide in the USA.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0994-2019
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Mar 4, 2019
- FDA report date
- Mar 13, 2019
- Quantity
- 58 cases
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Petra Hygienic Systems Int Ltd
Original FDA data
Every field from FDA enforcement report D-0994-2019, exactly as published.
Show all FDA fields
- City
- Concord
- Status
- Terminated
- Country
- Canada
- Event ID
- 82283
- Address
- 86 Moyal Crt
- Code information
- All Lots
- Report date
- Mar 13, 2019
- Product type
- Drugs
- Recall number
- D-0994-2019
- Classification
- Class III
- Recalling firm
- Petra Hygienic Systems Int Ltd
- Product quantity
- 58 cases
- Termination date
- Dec 10, 2020
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide in the USA.
- Recall initiation date
- Mar 4, 2019
- Initial firm notification
- Letter
- Center classification date
- Mar 12, 2019