FDAClass IIFebruary 5, 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, pai, Pharmaceutical Associates, Inc.…

Why was Nystatin Oral Suspension recalled?

Subpotent: Out of specification for assay at the 12-month time point.

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?

Lots: BB70, BB71 Exp. May 2020

Product
Nystatin Oral Suspension, USP 100,000 units per mL Cherry/Peppermint Flavor, 16 fl oz (473 mL) Rx Only, pai, Pharmaceutical Associates, Inc.…
Recalling firm
Pharmaceutical Associates Inc
Quantity
6288 16 oz bottles
Distribution
Distributed Nationwide in the US
Recall date
February 5, 2020
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls