Spartan Chemical Recalls Antiseptic Hand Cleaner Due to Manufacturing Deviations
Spartan Chemical Co Inc is recalling 400 gallons of Antiseptic Hand Cleaner due to CGMP deviations. The product was distributed nationwide in the US, Puerto Rico, and Mexico.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when associated with manufacturing deviations that may affect product quality or safety.
Plain-English summary
Spartan Chemical Co Inc has voluntarily recalled 400 one-gallon containers of Antiseptic Hand Cleaner (Chloroxylenol, 1.0%). The recall was initiated on March 29, 2021, and was classified as Class II by the FDA. The reason for the recall is cited as Current Good Manufacturing Practice (CGMP) deviations.
The affected product is identified by Lot 538885 with an expiration date of January 25, 2023. It is labeled for institutional and industrial use only. The product was distributed nationwide in the United States, Puerto Rico, and Mexico.
The recall was terminated on October 16, 2023. Consumers and institutions should check their inventory for this specific lot number and stop using the product if found.
The recalled product
- Product
- ANTISEPTIC HAND CLEANER (CHLOROXYLENOL)
- Brand
- ANTISEPTIC HAND CLEANER
- Manufacturer
- Spartan Chemical Co Inc
- Category
- Drug — OTC Drug
- Hazard
- Affected units
- 400
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot
- expiry: Lot 538885
- exp 1/25/2023
UPCs (1)
- 753727262571
Distribution
Part of a larger recall action
This product is one of 6 recalled by Spartan Chemical Co Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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