Class II · Moderate risk
Phenytoin Oral Suspension
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
National Drug Code
Is NDC 66689-0036-50 recalled?
Phenytoin Oral Suspension
Yes — this exact package was recalled
3 FDA recalls name the code 66689-0036-50 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 II · Moderate risk
Phenytoin Oral Suspension USP 125mg/5mL
Defective Container: A lidding deformity allowed for the product to have out of specification results for assay and viscosity at the12 month stability timepoint.
Class II · Moderate risk
Xactdose Phenytoin Oral Suspension
Defective container; lidding deformity allows the contained product to transpire causing potential viscosity and assay failures. The viscosity and assay failures were due to the loss of moisture. The loss of moisture caused the viscosity to increase and assay to increase relative to the sample volume.
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
- 66689-0008 See recall 4
- 66689-0023 See recall 3
- 66689-0031 See recall 3
- 66689-0038 See recall 3
- 66689-0039 See recall 2
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