FDAClass IIAugust 19, 2020

Nystatin Oral Suspension recall: Subpotent

Nystatin Oral Suspension, USP 100,000 units per mL, Cherry/Peppermint Flavor, 16 fl. oz. (473 mL), Rx only, Pharmaceutical Associates, Inc.…

Why was Nystatin Oral Suspension recalled?

Subpotent drug: Out of specification for assay at the 15-month test interval.

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: B973, Exp 11/20

Product
Nystatin Oral Suspension, USP 100,000 units per mL, Cherry/Peppermint Flavor, 16 fl. oz. (473 mL), Rx only, Pharmaceutical Associates, Inc.…
Recalling firm
PAI Holdings, LLC. dba Pharmaceutical Associates Inc
Quantity
7416 bottles
Distribution
Nationwide USA
Recall date
August 19, 2020
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls