Nystatin Oral Suspension recall: Impurity Out of Spec
Nystatin Oral Suspension, USP, 100,000 units per mL, 473 mL per bottle, Rx only, HI-TECH Pharmacal Co., Inc., Amityville, NY 11701, NDC 50383-587-16
Why was Nystatin Oral Suspension recalled?
Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during the 18 month stability 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#: 356527, Exp 3/19
- Product
- Nystatin Oral Suspension, USP, 100,000 units per mL, 473 mL per bottle, Rx only, HI-TECH Pharmacal Co., Inc., Amityville, NY 11701, NDC 50383-587-16
- Recalling firm
- Akorn, Inc.
- Quantity
- 2,796 bottles
- Distribution
- AR and MS
- Recall date
- April 10, 2019
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)