CETAFEN Extra Acetaminophen 500 mg caplets recalled for manufacturing deviations
Ultra Seal Corporation is recalling CETAFEN Extra Non-Aspirin Pain Relieve (Acetaminophen 500 mg) caplets in 2-count packets nationwide due to current good manufacturing practice (cGMP) deviations.
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 recall for cGMP deviations. The source text does not report any illnesses, injuries, or confirmed safety incidents—only manufacturing practice violations. Per the rubric, FDA Class II recalls without reported hospitalization are typically scored as 2 (Moderate).
Plain-English summary
Ultra Seal Corporation is voluntarily recalling CETAFEN Extra Non-Aspirin Pain Relieve (Acetaminophen 500 mg) caplets distributed nationwide in the United States. The recall affects approximately 1,019,000 packets with Lot #AK9475 and an expiration date of 02/2022.
The recall was initiated due to deviations from current good manufacturing practice (cGMP) standards. The FDA classified this as a Class II recall on January 31, 2022, and the firm began the recall on January 24, 2022.
Consumers who have purchased this product should stop use. For questions or to report adverse events, consumers should contact the recalling firm or their healthcare provider.
The recalled product
- Product
- CETAFEN Extra Non-Aspirin Pain Relieve (Acetaminophen 500 mg) caplets, 2-count packets, Manufactured for: HARTHealth Seattle, WA 98124
- Manufacturer
- Ultra Seal Corporation
- Hazard
- cgmp-deviation
- manufacturing-defect
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 (2)
- Lot #: AK9475
- Exp. Date 02/2022
Distribution
Distributed nationwide across the United States.
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