Extra Strength Un-Aspirin Acetaminophen Packets Recalled for cGMP Deviations
Ultra Seal Corporation has voluntarily recalled 1,694,200 packets of Extra Strength Un-Aspirin (acetaminophen 500 mg) distributed 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 manufacturing practice deviations with no reported illnesses or injuries cited in the source text. Per the severity rubric, Class II recalls without hospitalization or injury reports typically score 2 (Moderate), though manufacturing deviations fall within the voluntary precautionary recall category.
Plain-English summary
Ultra Seal Corporation is recalling Extra Strength Un-Aspirin (acetaminophen 500 mg) 2 Caplet packets distributed by ZEE Medical Distributors, LLC in Mason, Ohio. The recalled product has NDC 42961-041-03 and includes Lot #AK9599 (Expiration Date 05/2022) and Lot #AK9648 (L) 104 (Expiration Date 06/2022). Approximately 1,694,200 packets were distributed nationwide within the United States.
The recall was initiated by the firm on January 24, 2022, and classified as a Class II recall by the FDA on January 31, 2022. The reason for recall is cGMP deviations, which relate to violations of current Good Manufacturing Practice standards. This is a voluntary recall initiated by the manufacturer.
Consumers who have purchased this product should stop use and consult their healthcare provider if they have questions about alternative pain relief options. The recall was terminated on October 16, 2023.
The recalled product
- Product
- EXTRA STRENGTH UN-ASPIRIN (acetaminophen 500 mg) 2 Caplet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040, NDC 42961-041-03
- Manufacturer
- Ultra Seal Corporation
- Affected units
- 1,694,200
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 (5)
- Lot #: AK9599
- Exp. Date 05/2022
- AK9648
- (L) 104
- Exp. Date 06/2022
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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