Class III · Low risk
Nystatin Oral Suspension
Failed Impurties/Degradation Specifications: out of specification results for an impurity for one lot
National Drug Code
Is NDC 66689-0008-16 recalled?
Nystatin Oral Suspension
Yes — this exact package was recalled
3 FDA recalls name the code 66689-0008-16 directly. A recall still applies to particular lot numbers — compare the lot on your package with the FDA notice below, and talk to your pharmacist before stopping a prescribed medication.
This code is not in the current FDA NDC directory — usual for a product that has since been discontinued or repackaged. The details below come from the recall notices themselves.
Recalls naming this package
Class III · Low risk
Nystatin Oral Suspension
Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.
Class III · Low risk
Nystatin Oral Suspension
Failed Impurities/Degradation Specifications: Presence of an impurity peak that exceeds approved specification.
Class II · Moderate risk
Nystatin Oral Suspension
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Where to find this code. The NDC is printed on the pharmacy label and on the manufacturer's carton, usually as three groups of digits after “NDC”. The last group is the package size — two bottles of the same medicine can differ only in that group, and a recall may cover one but not the other.
Other recalled products from this labeler
- 66689-0037 See recall 5
- 66689-0023 See recall 3
- 66689-0031 See recall 3
- 66689-0036 See recall 3
- 66689-0038 See recall 3
- 66689-0039 See recall 2
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