Baclofen, 2.5 mg/mL INJ, in 100 mL vial, Rx Only, TexasStar Pharmacy, Plano, Texas 75023
FDA Recall #D-0733-2016 — Class II — December 29, 2015
Product Description
Baclofen, 2.5 mg/mL INJ, in 100 mL vial, Rx Only, TexasStar Pharmacy, Plano, Texas 75023
Reason for Recall
Lack of assurance of sterility
Recalling Firm
TexasStar Pharmacy — Plano, TX
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
700 mL (7 vials of 100 mL)
Distribution
TX
Code Information
Lot # 07142015#7192@1, Exp 09/12/2015; 09112015#7192@1, Exp 11/10/2015; 10082015#7192@9, Exp 12/07/2015; 11302015#71920@1, Exp 1/30/2015
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated