PAINAID PMF Premenstrual Formula Recalled for cGMP Deviations
Ultra Seal Corporation voluntarily recalled PAINAID PMF Premenstrual Formula packets nationwide due to cGMP (current Good Manufacturing Practice) 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: The recall is an FDA Class II voluntary, precautionary action based on manufacturing process deviations (cGMP). No illnesses, injuries, or adverse events are reported in the source text, and no specific product-quality defect or contamination is identified—only procedural manufacturing violations.
Plain-English summary
Ultra Seal Corporation initiated a voluntary nationwide recall of PAINAID PMF Premenstrual Formula (acetaminophen 500 mg, pamabrom 25 mg) in 2 caplet packets, distributed by ZEE Medical Distributors, LLC of Mason, Ohio. The recall was triggered by cGMP deviations in the manufacturing process.
Approximately 769,200 packets were distributed nationwide in the United States. The affected product is identified by Lot #AK9434, (L)101 with an expiration date of 01/2022, NDC 42961-0046-03.
The firm initiated the recall by letter on January 24, 2022, and the FDA classified it as Class II on January 31, 2022. The recall was terminated on October 16, 2023.
Consumers who have purchased this product should stop using it. For questions or product information, contact Ultra Seal Corporation or consult the FDA's online recall database.
The recalled product
- Product
- PAINAID PMF Premenstrual Formula (acetaminophen 500 mg, pamabrom 25mg) 2 caplet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040, NDC 42961-0046-03
- Manufacturer
- Ultra Seal Corporation
- Affected units
- 769,200
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 (3)
- Lot #: AK9434
- (L)101
- Exp. date 01/2022
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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