Class III · Low risk
Phytonadione Injectable Emulsion USP
Failed Stability Specifications: Out of specification results reported at 12-month stability testing for aluminum content.
National Drug Code
Is NDC 43598-0405-16 recalled?
Phytonadione Phytonadione · 25 AMPULE in 1 CARTON (43598-405-16) / 1 mL in 1 AMPULE (43598-405-11)
Yes — this exact package was recalled
2 FDA recalls name the code 43598-0405-16 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.
- Active ingredient
- Phytonadione
- Strength
- PHYTONADIONE 10 mg/mL
- Form
- Injection, Emulsion · Intramuscular, Intravenous, Subcutaneous
- Labeler
- Dr.Reddy's Laboratories Inc
- Type
- Human Prescription Drug
- Product code
- 43598-0405
Recalls naming this package
Class I · High risk
Phytonadione Injectable Emulsion
Defective Container: Recall is due to breaking and shattering of ampules upon opening
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
- 43598-0477 See recall 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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