FDA-Drug2016-12-28Class I

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

Hospira Inc., A Pfizer Company
Hazard

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

Sold states
Nationwide
Affected count
143,250 vials
Manufactured in
275 N Field Dr, N/A, Lake Forest, IL, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0218-2017

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