Phytonadione Injectable Emulsion Recalled Due to Out-of-Specification Aluminum Content
Dr. Reddy's Laboratories is recalling Phytonadione Injectable Emulsion due to failed stability testing that resulted in out-of-specification aluminum content. This Class III recall involves 2,838 ampules with no reported illnesses.
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 precautionary recall with no reported illnesses or injuries. The hazard is a failed stability specification revealing out-of-specification aluminum content. Per the rubric, FDA Class III recalls are typically scored 1 or 2, and precautionary recalls without reported adverse events score as Moderate.
Plain-English summary
Dr. Reddy's Laboratories, Inc. is recalling Phytonadione Injectable Emulsion USP, 10 mg/mL, which is distributed nationwide. The recall involves 2,838 ampules from Lot ACB101 with an expiration date of 03/2023.
Stability testing at the 12-month mark revealed aluminum content levels that were out of specification. No illnesses or injuries have been reported related to this product.
Phytonadione is a prescription medication used for anticoagulation reversal and treatment of vitamin K deficiency. The affected lot was distributed throughout the United States.
Patients and healthcare providers who have received this medication should contact their pharmacist or healthcare provider for guidance on this recall.
The recalled product
- Product
- PHYTONADIONE (PHYTONADIONE)
- Brand
- PHYTONADIONE
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Category
- Drug — Injectable / Parenteral
- Hazard
- aluminum-out-of-spec
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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