Heparin injection, Preservative Free, a) 280 units/0.28 mL, b) 350 units/0.35 mL syringe, c) 440 ...

FDA Recall #D-0527-2016 — Class II — November 10, 2015

Recall #D-0527-2016 Date: November 10, 2015 Classification: Class II Status: Terminated

Product Description

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

Reason for Recall

Lack of Assurance of Sterility

Recalling Firm

Walgreens Infusion Services — San Antonio, TX

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

49 syringes

Distribution

Texas

Code Information

All lots within expiry.

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated