PHYTONADIONE
Generic: PHYTONADIONE
Gland Pharma LimitedManufacturer
INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUSRoute
PHYTONADIONEActive Substance
2024-12-10Original Approval
PHYTONADIONE is FDA application ANDA217386, sponsored by GLAND. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.
Recalls
Class III2022-09-14
Phytonadione Injectable Emulsion USP, 10 mg/mL, 25x 1 mL single dose ampules per carton, Rx only, Distributed by: Dr. ReFailed Stability Specifications: Out of specification results reported at 12-month stability testing
Class II2025-10-31
Phytonadione Injectable Emulsion, USP 10mg/mL, 10x1 mL Single-Dose Vial/carton, Rx Only, Mfd. by: Cipla Ltd. India At M/Failed Stability Specifications: Observed OOS results: eg results for colour index
Class I2020-03-16
Phytonadione Injectable Emulsion, USP, 10 mg/mL 1 mL ampule (NDC 43598-405-11) packaged in 25 x 1 mL Single-Dose AmpulesDefective Container: Recall is due to breaking and shattering of ampules upon opening
Top Reported Reactions
1
SEPSIS
334 reports
2
NAUSEA
316 reports
3
OFF LABEL USE
308 reports
4
VOMITING
308 reports
5
ABDOMINAL DISTENSION
298 reports
6
HYPONATRAEMIA
288 reports
7
ABDOMINAL PAIN
285 reports
8
GENERAL PHYSICAL HEALTH DETERIORATION
285 reports
9
ASCITES
281 reports
10
MULTIPLE ORGAN DYSFUNCTION SYNDROME
277 reports