D-0733-2016 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- March 9, 2016
- Initiation Date
- December 29, 2015
- Termination Date
- November 17, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 700 mL (7 vials of 100 mL)
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
Distribution Pattern
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