Phytonadione injectable emulsion fails stability specifications in nationwide recall
Cipla Limited is recalling 4,438 cartons of Phytonadione Injectable Emulsion USP 10mg/mL for failing stability specifications with out-of-specification color index results. Distributed nationwide.
What this means for you
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: FDA Class II recall for stability specification failure without reported illnesses or injuries. The hazard is a manufacturing specification defect (out-of-specification color index) in a precautionary recall.
Plain-English summary
Cipla Limited is recalling Phytonadione Injectable Emulsion, USP 10mg/mL in 10x1 mL single-dose vials. The recall is due to failure to meet stability specifications, specifically out-of-specification results for color index. This is a Class II recall.
The affected product consists of 4,438 cartons with batch numbers PH0072404A and PH0082404A, with an expiration date of December 31, 2025. The product was distributed nationwide in the United States.
The recalled product can be identified by NDC number 69097-708-96 on the carton or 69097-708-31 on the vial.
The recalled product
- Product
- PHYTONADIONE (PHYTONADIONE)
- Brand
- PHYTONADIONE
- Manufacturer
- Cipla Limited
- Category
- Drug — Vitamin K injection
- Hazard
- stability-failure
- color-index
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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