Drug product
Baclofen, 2.5 mg/mL INJ, in 100 mL vial, Rx Only, TexasStar Pharmacy, Plano, Texas 75023
D-0733-2016
Product summary
- Event
- Event 72958
- Status
- Terminated
- Classification
- Class II
- Quantity
- 700 mL (7 vials of 100 mL)
- Official record key
drug-enforcement:D-0733-2016
Official wording
Reason: Lack of assurance of sterility
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
Distribution pattern: TX
Derived failure modes
-
Unknown
Lack of assurance of sterility