Phytonadione injectable emulsion vials recalled after failing stability testing specifications
Cipla Limited is recalling 4,438 cartons of Phytonadione Injectable Emulsion, USP 10mg/mL, after the product failed stability specifications with out-of-specification colour index results.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 because the record cites an out-of-specification stability result with no stated clinical consequence or reported harm.
Plain-English summary
Phytonadione Injectable Emulsion, USP 10mg/mL, supplied as 10 x 1 mL single-dose vials per carton, is being recalled. The prescription product is manufactured by Cipla Ltd. India at M/s Immacule Lifesciences PVT. Ltd. India for Cipla USA, Inc. of Warren, New Jersey, under vial NDC 69097-708-31.
The recall follows failed stability specifications, with out-of-specification results observed for the colour index.
The recall covers 4,438 cartons from batches PH0072404A and PH0082404A, with expiry date December 31, 2025. Distribution was nationwide in the USA. The FDA has classified the action as Class II.
The record describes a stability testing failure rather than a reported patient harm. Facilities should quarantine affected batches and follow Cipla's instructions.
The recalled product
- Product
- PHYTONADIONE (PHYTONADIONE)
- Brand
- PHYTONADIONE
- Manufacturer
- Cipla Limited
- Category
- Drug — Injectable
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Batch # PH0072404A
- PH0082404A
- Exp. Date December 31
- 2025
Distribution
Distributed nationwide across the United States.
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