Dr. Reddy's Recalls Phytonadione Ampules Due to Breaking and Shattering
Dr. Reddy's is recalling Phytonadione Injectable Emulsion ampules because they may break or shatter when opened.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 per the rubric.
Plain-English summary
Dr. Reddy's Laboratories, Inc. is recalling Phytonadione Injectable Emulsion, USP, 10 mg/mL 1 mL ampules. The recall is due to defective containers that may break or shatter upon opening.
The affected product is packaged in 25 x 1 mL Single-Dose Ampules per carton. The recall covers 10,943 cartons distributed nationwide within the United States. Specific lots include ACB902 and ACB903 (Exp. 03/2021), ACB904 (Exp. 04/2021), and ACB905 (Exp. 06/2021).
Healthcare providers and patients should stop using the affected ampules and contact Dr. Reddy's Laboratories for further instructions.
The recalled product
- Product
- PHYTONADIONE (PHYTONADIONE)
- Brand
- PHYTONADIONE
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Category
- Drug — Injectable
- Affected units
- 10,943
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 (7)
- Lot #: ACB902
- ACB903
- Exp. Date 03/2021
- ACB904
- Exp. Date 04/2021
- ACB905
- Exp. Date 06/2021
Distribution
Distributed nationwide across the United States.
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