Drug recall D-0456-2017
Product
MIDAZOLAM INJECTION, USP, *25 mg/5 mL, (5 mg/ mL), 5 mL vials, 10 Vials per carton, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173 --- NDC 63323-412-05
Reason for recall
Failed Impurities/Degradation Specifications
Lots and codes
Lot 6007327, exp. 01-2017; Lot 6007329, exp. 01-2017
Recall details
- Recalling firm
- Fresenius Kabi USA, LLC, Lake Zurich, IL
- Quantity
- 47, 020 vials
- Distribution
- Nationwide and Puerto Rico
- Type
- Voluntary: Firm initiated
- Recall initiated
- December 16, 2016
- Terminated
- June 22, 2018
Related products
- Midazolam – drug information
- NDC 63323-411 Midazolam · Midazolam Hydrochloride 1 mg/mL · Fresenius Kabi USA, LLC
- NDC 63323-412 Midazolam · Midazolam Hydrochloride 5 mg/mL · Fresenius Kabi USA, LLC