FDAClass IIIJune 13, 2018

Nystatin Oral Suspension recall

Nystatin Oral Suspension, USP, 500,000 units/5 mL, For Institutional Use Only, packaged in 5 mL cups, Rx Only, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-4810-05

Why was Nystatin Oral Suspension recalled?

Resuspension problems: Out of specification for appearance and resuspendability.

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: B5B8 Exp. 07/2019

Product
Nystatin Oral Suspension, USP, 500,000 units/5 mL, For Institutional Use Only, packaged in 5 mL cups, Rx Only, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-4810-05
Recalling firm
Pharmaceutical Associates Inc
Quantity
275400 cups
Distribution
Nationwide
Recall date
June 13, 2018
Classification
Class III
Status
Terminated
Agency
FDA (drug)
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