Nystatin Oral Suspension recall: Subpotent
Nystatin Oral Suspension, USP, 100,000 units per mL, Cherry/Peppermint Flavor, 16 fl oz (473 mL) bottle, Rx ONLY, pai Pharmaceutical Associates, Inc.…
Why was Nystatin Oral Suspension recalled?
SubPotent Drug: Low out-of-specification results for assay testing.
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: BE85, Exp. 11/2020
- Product
- Nystatin Oral Suspension, USP, 100,000 units per mL, Cherry/Peppermint Flavor, 16 fl oz (473 mL) bottle, Rx ONLY, pai Pharmaceutical Associates, Inc.…
- Recalling firm
- PAI Holdings, LLC. dba Pharmaceutical Associates Inc
- Quantity
- 7416 bottles
- Distribution
- Nationwide in the USA.
- Recall date
- April 1, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)