The Recall Desk
HighFDA (Drugs)·D-0527-2016·Announced 2016-01-06

Walgreens Recalls Heparin Injection Syringes Due to Sterility Concerns

Walgreens Infusion Services is recalling 49 syringes of Heparin injection, Preservative Free, due to a lack of assurance of sterility. The affected products were distributed in Texas.

What this means for you

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 is classified as FDA Class II due to a lack of assurance of sterility, which poses a risk of infection or other adverse health consequences, but no specific illnesses or injuries are reported in the source text.

Plain-English summary

Walgreens Infusion Services is voluntarily recalling 49 syringes of Heparin injection, Preservative Free. The recall is being conducted because of a lack of assurance of sterility in the compounded product. The affected product is compounded by Option Care 148 in San Antonio, Texas, and is available in various concentrations including 280 units/0.28 mL, 350 units/0.35 mL, 440 units/0.44 mL, 500 units/0.5 mL, 800 units/0.8 mL, and 2300 units/2.3 mL.

The recall covers all lots within their expiration dates. The distribution of the affected product was limited to Texas. The U.S. Food and Drug Administration has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Patients who have received this product should contact their healthcare provider for guidance. Consumers should not use the recalled syringes and should return them to the pharmacy or healthcare provider where they were obtained.

The recalled product

Product
Heparin injection, Preservative Free, a) 280 units/0.28 mL, b) 350 units/0.35 mL syringe, c) 440 units/0.44 mL, d) 500 units/0.5 mL syringe, e) Heparin 800 units/0.8 f) Heparin 2300 units/2.3 mL syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Affected units
49

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 →