The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0545-2016·Announced 2016-01-06

Walgreens Recalls Insulin Syringes Due to Sterility Assurance Concerns

Walgreens Infusion Services is recalling 23 insulin 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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (sterility issue) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Walgreens Infusion Services is recalling 23 units of Insulin Regular (Human) syringes. The affected products include 15 unit/0.15 mL, 24 unit/0.24 mL, and 50 unit/0.5 mL syringes, which are prescription-only and compounded by Option Care 148 in San Antonio, Texas. The recall covers all lots within their expiration dates.

The recall was initiated due to a lack of assurance of sterility. The products were distributed in Texas.

Consumers who have these specific syringes should stop using them and contact their healthcare provider or pharmacist for further instructions.

The recalled product

Product
Insulin Regular (Human) syringe, a)15 unit/0.15 mL, b) 24 unit/0.24mL syringe, c) 50 unit/0.5 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Manufacturer
Walgreens Infusion Services
Category
Drug — Insulin Syringes
Hazard
Affected units
23

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 →

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