Class II · Moderate risk
Phytonadione Injectable Emulsion
Failed Stability Specifications: Observed OOS results: eg results for colour index
Phytonadione Tablets 5 mg
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Impurities Specification: Out of specification when measuring the impurity degradant D level.
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
What was recalled
Phytonadione Tablets 5 mg, Rx Only, 30 Tablets (3x10) Unit Dose, Manufactured for: AvKARE Pulaski, TN 38478. NDC 50268-661-13
Affected NDC
50268-0661-13
Compare with the code on your package — it is the most precise check available.
Drug: Phytonadione
- Recalling firm
- AVKARE Inc.
- NDC code
- 50268-661-13
- Origin
- TN, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0631-2021 · 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 Phytonadione recalls
See all
Class II · Moderate risk
VITAMIN K (Phytonadione)
Lack of sterility assurance
Class III · Low risk
Phytonadione Injectable Emulsion USP
Failed Stability Specifications: Out of specification results reported at 12-month stability testing for aluminum content.
Class III · Low risk
Phytonadione Tablets
Failed Impurities/Degradation Specifications
Class III · Low risk
Mephyton (Phytonadione)
Failed Impurities/Degradation Specifications
Other recalls by AVKARE Inc.
All 2021 recalls
Class II · Moderate risk
Amantadine HCl
Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution.
Class II · Moderate risk
Rosuvastatin Tablets
Out of specification for dissolution.
Class II · Moderate risk
Norgestimate and Ethinyl Estradiol Tablets
Failed Content Uniformity Specifications
Class II · Moderate risk
chloroproMAZINE Hydrochloride Tablets
Presence of a foreign substance.
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