Phytonadione Injectable Emulsion recalled for failed stability testing
Dr. Reddy's Laboratories is recalling Phytonadione Injectable Emulsion USP due to out-of-specification aluminum content results found during 12-month stability testing.
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: This is an FDA Class III recall, which by definition is unlikely to cause adverse health consequences. The hazard is a manufacturing/stability issue with no reported illnesses or injuries, making it a low-risk, precautionary recall.
Plain-English summary
Dr. Reddy's Laboratories, Inc. is recalling Phytonadione Injectable Emulsion USP, 10 mg/mL, distributed nationwide. The recall was initiated because stability testing at 12 months revealed aluminum content results that were out of specification.
Phytonadione is a prescription injectable medication containing Vitamin K, used to reverse anticoagulation and increase prothrombin activity. It is administered by intramuscular, intravenous, or subcutaneous injection.
The affected lot is ACB101 with expiration date 03/2023, consisting of 2,838 ampules (25 single-dose ampules per carton, NDC 43598-405-16).
Patients using this medication should contact their healthcare provider or pharmacist. Do not stop taking or using this medication without speaking to a healthcare professional, as abrupt discontinuation could have serious consequences.
The recalled product
- Product
- PHYTONADIONE (PHYTONADIONE)
- Brand
- PHYTONADIONE
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Category
- Drug — Injectable / Vitamin K
- Hazard
- failed-stability-testing
- aluminum-contamination
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 (2)
- Lot # ACB101
- Exp 03/2023
Distribution
Distributed nationwide across the United States.
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