Class I · High risk
Sapropterin Dihydrochloride Powder for Oral Solution 100mg
Sub-potent Drug; powder discoloration associated with decreased potency
National Drug Code
Is NDC 43598-0477-11 recalled?
Sapropterin Dihydrochloride Powder for Oral Solution 100mg
Yes — this exact package was recalled
1 FDA recall names the code 43598-0477-11 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.
1 of these recalls is still ongoing.
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
Sapropterin Dihydrochloride Powder for Oral Solution
Subpotent Drug: Out-of-specification results observed in Assay in sapropterin dihydrochloride powder 100mg.
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
- 43598-0315 Amlodipine besylate and Atorvastatin calcium 2
- 43598-0405 Phytonadione Phytonadione 2
- 43598-0510 Esomeprazole Magnesium 2
- 43598-0561 Lansoprazole 2
- 43598-0743 Ezetimibe and Simvastatin 2
- 43598-0823 Fexofenadine HCl and Pseudoephedrine HCI 2
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