Class II · Moderate risk Ongoing
Phytonadione Injectable Emulsion
Reason Failed Stability Specifications: Observed OOS results: eg results for colour index
PHYTONADIONE Tablet
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Labeling: Label Mixup; PHYTONADIONE Tablet, 5 mg may be potentially mislabeled as medroxyPROGESTERone ACETATE, Tablet, 10 mg, NDC 59762374202, Pedigree: AD46312_19, EXP: 5/16/2014; HYDROCORTISONE, Tablet, 5 mg, NDC 00603389919, Pedigree: W003060, EXP: 6/12/2014; GALANTAMINE HBR ER, Capsule, 24 mg, NDC 47335083783, Pedigree: W003735, EXP: 5/31/2014; TORSEMIDE, Tablet, 10 mg, NDC 31722053001,
What was recalled
PHYTONADIONE Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 25010040515
- Recalling firm
- Aidapak Services, LLC
- Origin
- WA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-539-2014
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Phytonadione recalls
See all
Class II · Moderate risk Terminated
Vitamin K
Reason Lack of sterility assurance
Class III · Low risk Completed
Phytonadione Injectable Emulsion USP
Reason Failed Stability Specifications: Out of specification results reported at 12-month stability testing for aluminum content.
Class III · Low risk Terminated
Phytonadione Tablets 5 mg
Reason Failed Impurities Specification: Out of specification when measuring the impurity degradant D level.
Class III · Low risk Terminated
Phytonadione Tablets
Reason Failed Impurities/Degradation Specifications
Get an alert if your medication is recalled
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.