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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
- Affected units
- 223,090
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.
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.
See all 56 products in this recall →Related recalls
Same manufacturer · Ultra Seal Corporation
See all →- ModeratePEPTIME Energy Caffeine Tablets Recalled for cGMP Deviations
FDA (Drugs) · 2022-02-09
- ModerateExaprin Pain Reliever Tablets Recalled for cGMP Deviations
FDA (Drugs) · 2022-02-09
- ModerateCold Terminator decongestant recalled for cGMP deviations
FDA (Drugs) · 2022-02-09
- ModerateLite Remfresh Melatonin Tablets Recalled for cGMP Deviations
FDA (Drugs) · 2022-02-09
- ModerateExtra Strength Un-Aspirin Acetaminophen Packets Recalled for cGMP Deviations
FDA (Drugs) · 2022-02-09
Same hazard · manufacturing defect
See all →- ModerateBoston Scientific Recalls NaviFlex LW Pusher and Advx Panc. Stent
FDA (Devices) · 2026-10-21
- ModerateCook Williams Cystoscopic Injection Needles Recalled for Manufacturing Defect
FDA (Devices) · 2026-10-21
- ModerateNeuronetics Recalls NeuroStar Advanced Therapy Systems Due to Non-Conforming Cables
FDA (Devices) · 2026-10-21
- HighBeak & Skiff Alcohol Antiseptic Sanitizer recalled for acetaldehyde contamination
FDA (Drugs) · 2026-10-14
- ModerateCustom Interventional Pain Management Recalls Mastisol Skin Adhesive Trays
FDA (Devices) · 2026-10-07
Similar recalls
- ModerateNormed Fem Tablet Recalled Due to CGMP Deviations
FDA (Drugs) · 2022-02-16
- ModeratePain Aid PMF Caplet Drug Recall for CGMP Deviations
FDA (Drugs) · 2022-02-16
- ModerateDrug Recall: Coated Back Relief Tablet CGMP Deviations
FDA (Drugs) · 2022-02-16
- ModerateAcetaminophen 325 mg Pamabrom Tablets Recalled Due to Manufacturing Violations
FDA (Drugs) · 2022-02-16
- ModerateDrug Recall: Acetaminophen Phenylephrine Tablets for CGMP Deviations
FDA (Drugs) · 2022-02-16
- ModeratePhysicians CARE Extra Strength Pain Reliever recalled for CGMP deviations
FDA (Drugs) · 2022-01-26