Bupivacaine Hydrochloride Inj., USP (2.5 mg/mL) 0.25%, packaged in 30 mL Single-dose Preservative-Free vials, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1159-02

FDA recall notice · announced December 28, 2016 · Hospira Inc., A Pfizer

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

The product

Bupivacaine Hydrochloride Inj., USP (2.5 mg/mL) 0.25%, packaged in 30 mL Single-dose Preservative-Free vials, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1159-02

Reason for recall

Presence of particulate matter: Confirmed customer report for the presence of particulate matter within a single vial.

Notes

Distribution: Nationwide
Lot/code information: Lot # 59064DK, Exp. 11/17
Quantity: 143,250 vials
Status: Ongoing
Products in this recall event:
- Bupivacaine Hydrochloride Inj., USP (2.5 mg/mL) 0.25%, packaged in 30 mL Single-dose Preservative-Free vials, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1159-02 (D-0218-2017)

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