The Recall Desk
SevereFDA (Drugs)·D-0541-2016·Announced 2016-01-06

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.

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 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.

See all 33 products in this recall →

Related recalls

Same manufacturer · Walgreens Infusion Services

See all →

Same hazard · sterility

See all →