PAPENOL acetaminophen 500 mg packets recalled for cGMP deviations
Ultra Seal Corporation is recalling PAPENOL acetaminophen 500 mg (2 tablet packets) nationwide due to cGMP (current Good Manufacturing Practice) deviations. The recall affects 533,100 packets with lot numbers K9495 (exp. 02/2022) and AK9614 (exp. 05/2022).
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 with no reported illnesses or injuries cited in the source text. The hazard—cGMP deviations—is a manufacturing-process defect without documented patient harm. The firm initiated the recall voluntarily, and no hospitalization or serious injury reports are mentioned, supporting a Moderate severity rating.
Plain-English summary
Ultra Seal Corporation, the recalling firm, is voluntarily recalling PAPENOL acetaminophen 500 mg tablets sold in 2 tablet packets. The product is manufactured for Afassco Inc. in Minden, Nevada. The recall was initiated on January 24, 2022, and classified as FDA Class II on January 31, 2022.
The recall is due to cGMP (current Good Manufacturing Practice) deviations identified during the manufacturing process. A total of 533,100 packets are affected, distributed nationwide within the United States.
The affected lots are: Lot #K9495 with expiration date 02/2022 and Lot #AK9614 with expiration date 05/2022. Consumers in possession of these products should stop using them. The recall was terminated on October 16, 2023.
The recalled product
- Product
- PAPENOL (acetaminophen 500 mg), 2 tablet packets, Manufactured for: Afassco Inc. Minden, NV 89423
- Manufacturer
- Ultra Seal Corporation
- Affected units
- 533,100
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 #: K9495
- Exp. Date 02/2022
- AK9614
- Exp. Date 05/2022
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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