Unclassified
Nystatin Cream
Failed Stability Specifications
Nystatin Oral Suspension
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Resuspension problems: Out of specification for appearance and resuspendability.
Cause type: Failed specification
A physical or chemical test other than potency, dissolution, impurity or stability failed - pH, viscosity, appearance, tablet integrity, fill volume. A product outside its own specification may not perform as designed, even if the active ingredient is present. All failed specification recalls.
What was recalled
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
Affected NDC
0121-4810-05
Compare with the code on your package — it is the most precise check available.
Drug: Nystatin
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Nystatin NDC 00121-4810 |
100000 [USP'U]/mL | Suspension Oral |
Pharmaceutical Associates, Inc. | Rx |
- Recalling firm
- Pharmaceutical Associates Inc
- NDC code
- 0121-4810-05
- Origin
- SC, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0865-2018 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Nystatin recalls
See all
Class II · Moderate risk
Nystatin Cream USP
Subpotent Drug: Low out of specification assay results performed during long-term stability testing.
Class II · Moderate risk
Nystatin 150 Mu
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Class II · Moderate risk
Nystatin 2 Bu
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Class II · Moderate risk
Nystatin 500 Mu
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Other recalls by Pharmaceutical Associates Inc
All 2018 recalls
Class II · Moderate risk
Nystatin Oral Suspension
Subpotent: Out of specification for assay at the 12-month time point.
Class II · Moderate risk
Cyproheptadine HCl Syrup
Failed Impurities/Degradation Specifications : Out-of-specification result for an unidentified impurity at the 12 month stability test point.
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