Drug Recall: PAINAID Tablets for Manufacturing Deviations
Ultra Seal Corporation is recalling approximately 2.3 million packets of PAINAID pain relief tablets nationwide due to cGMP (current Good Manufacturing Practice) deviations in manufacturing processes.
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 involving cGMP manufacturing deviations. No illnesses, injuries, or deaths are reported in the source text, and the source does not specify the nature of the manufacturing defect beyond "cGMP deviations." Per the rubric, Class II recalls without reported harm typically score 2 (Moderate).
Plain-English summary
Ultra Seal Corporation is recalling PAINAID, a combination pain relief tablet containing acetaminophen 110 mg, aspirin 162 mg, caffeine 32.4 mg, and salicylamide 152 mg, sold in 2-tablet packets. The product is distributed nationwide in the United States by ZEE Medical Distributors, LLC of Mason, Ohio. Approximately 2,336,600 packets are affected.
The recall was initiated due to cGMP (current Good Manufacturing Practice) deviations identified in the manufacturing process. This is a voluntary recall initiated by the firm. The affected lots are Lot #AK9433 (Expiration Date 01/2022) and Lot #AK9749 (Expiration Date 08/2022).
Consumers in possession of affected PAINAID packets should stop using the product. The FDA classification for this recall is Class II. The recall was initiated on January 24, 2022, and terminated on October 16, 2023.
The recalled product
- Product
- PAINAID (acetaminophen 110 mg, aspirin 162mg, caffeine 32.4 mg, salicylamide 152mg) 2 tablet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040
- Manufacturer
- Ultra Seal Corporation
- Category
- Drug — Pain Relief
- Hazard
- manufacturing-deviation
- cGMP-violation
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 #: AK9433
- Exp. Date 01/2022
- AK9749
- Exp. Date 08/2022
Distribution
Distributed nationwide across the United States.
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