0.5% Bupivacaine HCl and Epinephrine 1:200,000 Inj., 10 mL, Single-Dose Vial, NDC 0409-9045-01, Hospira, Inc., Lake Forest, IL 60045

FDA recall notice · announced October 16, 2013 · Hospira

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

The product

0.5% Bupivacaine HCl and Epinephrine 1:200,000 Inj., 10 mL, Single-Dose Vial, NDC 0409-9045-01, Hospira, Inc., Lake Forest, IL 60045

Reason for recall

Lack of Assurance of Sterility; potential for vial breakage

Notes

Distribution: Nationwide and Guam and Abu Dhabi
Lot/code information: Lot 17-400-EV* and 17-401-EV * Note: the lot number may be followed by 01
Quantity: 187,150 vials
Status: Terminated
Products in this recall event:
- 0.5% Bupivacaine HCl and Epinephrine 1:200,000 Inj., 10 mL, Single-Dose Vial, NDC 0409-9045-01, Hospira, Inc., Lake Forest, IL 60045 (D-66295-001)

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