FDAClass IIMarch 9, 2016

Baclofen recall: Sterility Concern

Baclofen, 2.5 mg/mL INJ, in 100 mL vial, Rx Only, TexasStar Pharmacy, Plano, Texas 75023

Why was Baclofen recalled?

Lack of assurance of sterility

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Baclofen, 2.5 mg/mL INJ, in 100 mL vial, Rx Only, TexasStar Pharmacy, Plano, Texas 75023
Recalling firm
TexasStar Pharmacy
Quantity
700 mL (7 vials of 100 mL)
Distribution
TX
Recall date
March 9, 2016
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls