FDAClass IIFebruary 9, 2022

PAINAID PMF Premenstrual Formula recall: CGMP Deviations

PAINAID PMF Premenstrual Formula (acetaminophen 500 mg, pamabrom 25mg) 2 caplet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040, NDC…

Why was PAINAID PMF Premenstrual Formula recalled?

cGMP deviations

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: AK9434, (L)101, Exp. date 01/2022

Product
PAINAID PMF Premenstrual Formula (acetaminophen 500 mg, pamabrom 25mg) 2 caplet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040, NDC…
Recalling firm
Ultra Seal Corporation
Quantity
769,200 packets
Distribution
Nationwide within the United States
Recall date
February 9, 2022
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls