Cetafen acetaminophen tablets recalled for manufacturing deviations
Ultra Seal Corporation is recalling Cetafen Non-aspirin pain reliever (acetaminophen 325mg) tablets in 2-count packets due to current good manufacturing practice (cGMP) deviations. The recall affects 915,770 packets distributed nationwide.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II voluntary recall for cGMP deviations without reported illnesses or injuries. Class II recalls typically indicate a situation where use of the product may cause adverse health consequences or death, but the source text does not report any actual harm or hospitalizations.
Plain-English summary
Ultra Seal Corporation is recalling Cetafen Non-aspirin pain reliever (acetaminophen 325mg) tablets in 2-count packets. The affected product includes Lot #A-K-9668 (Exp. Date 06/2022) and Lot #A-K-9475 (Exp. Date 02/2022), manufactured for HARTHealth in Seattle, WA.
The recall was initiated due to current good manufacturing practice (cGMP) deviations. This is a voluntary recall initiated by the firm.
Approximately 915,770 packets were distributed nationwide within the United States. The Food and Drug Administration classified this as a Class II recall. Consumers with affected product should discontinue use and consult their healthcare provider with questions.
The recalled product
- Product
- Cetafen Non-aspirin pain reliever (acetaminophen 325mg) tablets, 2-count packets, Manufactured for: HARTHealth Seattle, WA 98124
- Manufacturer
- Ultra Seal Corporation
- Hazard
- Affected units
- 915,770
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 (4)
- Lot #: A-K-9668
- Exp. Date 06/2022
- A-K-9475
- Exp. Date 02/2022
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 56 recalled by Ultra Seal Corporation 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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