METRONIDazole Injection, USP 500 mg (5 mg/mL) in 100 mL Single Dose Flexible Container, Rx only, For IV Use, Hospira Inc., Lake Forest, IL --- NDC 0409-7811-24
FDA recall notice · announced March 1, 2017 · Hospira Inc., A Pfizer
Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.
The product
METRONIDazole Injection, USP 500 mg (5 mg/mL) in 100 mL Single Dose Flexible Container, Rx only, For IV Use, Hospira Inc., Lake Forest, IL --- NDC 0409-7811-24
Reason for recall
Lack of Sterility Assurance: customer report of leaking bag
Notes
Distribution: Nationwide and Puerto Rico
Lot/code information: Lot: 54-054-JT, 6/1/2017
Quantity: 578,784 bags
Status: Terminated
Products in this recall event:
- METRONIDazole Injection, USP 500 mg (5 mg/mL) in 100 mL Single Dose Flexible Container, Rx only, For IV Use, Hospira Inc., Lake Forest, IL --- NDC 0409-7811-24 (D-0480-2017)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.