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

FDA recall notice · announced February 8, 2017 · Fresenius Kabi

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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

Notes

Distribution: Nationwide and Puerto Rico
Lot/code information: Lot 6007327, exp. 01-2017; Lot 6007329, exp. 01-2017
Quantity: 47, 020 vials
Status: Terminated
Products in this recall event:
- 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 (D-0456-2017)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.