WB-Tranexamic acid, 2 g/Placebo 100 mL, DRUG STUDY, packaged as a) 100 mL INJECTABLE, b) TOPICAL...
FDA Recall #D-456-2014 — Class II — October 19, 2013
Product Description
WB-Tranexamic acid, 2 g/Placebo 100 mL, DRUG STUDY, packaged as a) 100 mL INJECTABLE, b) TOPICAL, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
Reason for Recall
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Recalling Firm
Specialty Medicine Compounding Pharmacy — South Lyon, MI
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
a) 1900 injectable; b) 1900 mL topical
Distribution
Hospitals, clinics, physicians, and patients in the Michigan area only.
Code Information
All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: a) Injectable lots: 09272013@14, 09272013@4, 09272013@8, 09272013@18, 10142013@3, 10142013@9, 10142013@13, 10142013@15, 10142013@19, 09272013@3, 09272013@7, 09272013@11, 09272013@13, 09272013@17, 10142013@6, 10142013@8, 10142013@12, 10142013@18, 10142013@22; b) Topical lots: 09272013@2, 09272013@6, 09272013@10, 09272013@12, 09272013@16, 10142013@5, 10142013@7, 10142013@11, 10142013@17, 10142013@21, 09272013@5, 09272013@9, 09272013@15, 09272013@19, 10142013@4, 10142013@10, 10142013@14, 10142013@16, 10142013@20
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.