Walgreens Recalls Phytonadione Syringes Due to Sterility Concerns
Walgreens Infusion Services is recalling compounded Phytonadione (Vitamin K) syringes in Texas due to a lack of assurance of sterility.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly identifies the agency classification as Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe).
Plain-English summary
Walgreens Infusion Services is recalling 20 syringes of Phytonadione (Vitamin K) 1 mg/0.1mL, prescription only. The product was compounded by Option Care 148 in San Antonio, Texas, and distributed within Texas. All lots within the expiry date are affected.
The recall was initiated due to a lack of assurance of sterility. The FDA has classified this as a Class II recall.
Consumers should stop using the product and contact their healthcare provider or pharmacist for further instructions.
The recalled product
- Product
- Phytonadione (Vitamin K) 1 mg/0.1mL Syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
- Manufacturer
- Walgreens Infusion Services
- Category
- Drug — Injectable
- Hazard
- Affected units
- 20
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 (1)
- All lots within expiry.
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 33 recalled by Walgreens Infusion Services under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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