The Recall Desk
ModerateFDA (Drugs)·D-0509-2022·Announced 2022-02-09

Drug Recall: FEM-PRIN Menstrual Relief Tablets for cGMP Deviations

Ultra Seal Corporation is recalling FEM-PRIN Menstrual Relief tablets (223,090 packets) distributed nationwide due to cGMP deviations. The recall was voluntary and initiated on January 24, 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 initiated voluntarily by the firm due to cGMP deviations. The source text does not report any illnesses, injuries, or hospitalizations. Under the rubric, Class II recalls without reported harm are classified as Moderate (score 2).

Plain-English summary

Ultra Seal Corporation is voluntarily recalling FEM-PRIN MENSTRUAL RELIEF tablets containing acetaminophen 325 mg and pamabrom 25 mg in 2-count packets, manufactured for HARTHealth in Seattle, WA. The affected product is Lot #AK9695 with an expiration date of 07/2022, with a total of 223,090 packets recalled.

The recall was initiated on January 24, 2022, due to cGMP (current Good Manufacturing Practice) deviations. The product was distributed nationwide within the United States.

Consumers who have purchased this product should stop using it. Those with questions about the recall may contact the recalling firm, Ultra Seal Corporation.

The recalled product

Product
FEM-PRIN MENSTRUAL RELIEF (acetaminophen 325 mg, pamabrom 25mg) tablets, 2-count packets, Manufactured for: HARTHealth Seattle, WA 98124
Manufacturer
Ultra Seal Corporation
Category
Drug — Over-the-Counter Pain Relief
Hazard
  • manufacturing-defect
  • cgmp-deviation

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 #: AK9695
  • Exp. Date 07/2022

Distribution

Distributed nationwide across the United States.

Related recalls

Same category