Recall record at a glance
| Official record | D-0869-2017 |
|---|---|
| Category | Drug Recalls |
| Classification | Class III |
| FDA record status | Terminated |
| Recalling firm | VistaPharm, Inc. |
| Report date | Jun 7, 2017 |
| Recall initiation date | May 17, 2017 |
| Quantity | 2,208,500 cups/18696 bottles |
| Location | Largo, FL, United States |
Official product description
Nystatin Oral Suspension, USP, 100,000 units/mL, packaged in a) 2 fl.oz. (60mL) bottles (NDC 66689-008-02), and 500,000 units/5mL individual unit dose cup (NDC 66689-037-01) packaged in b) 50 count unit dose cups/case (NDC 66689-037-50) and c) 100 count unit dose cups/case (NDC 66689-037-99) Rx only, Manufactured by: VistaPharm, Largo, FL 33771.
Why the product was recalled
Failed Impurities/Degradation Specifications: Presence of an impurity peak that exceeds approved specification.
Distribution information
Nationwide in the US and Puerto Rico
How to read the classification
FDA Class III generally covers situations in which use of or exposure to the product is not likely to cause adverse health consequences. The classification displayed here is taken from the FDA enforcement record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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