FDA Drug recall D-1216-2015

Bupivacaine Hydrochloride Inj., USP, 0.5% (5 mg/mL), Preservative-Free, 30 mL Single Use Vials, Rx only

• FDA Drug
• Class I
• terminated
• Published 2015-07-15

On 2015-07-15 the FDA classified a Class I recall of Bupivacaine Hydrochloride Inj., USP, 0.5% (5 mg/mL), Preservative-Free, 30 mL Single Use Vials, Rx only by Hospira, citing presence of Particulate Matter: Presence of free-floating and embedded iron oxide particles.

Read the official FDA Drug notice

Product

Bupivacaine Hydrochloride Inj., USP, 0.5% (5 mg/mL), Preservative-Free, 30 mL Single Use Vials, Rx only. HOSPIRA, INC., LAKE FOREST, IL 60045 USA. NDC: 0409-1162-02.

Reason

Presence of Particulate Matter: Presence of free-floating and embedded iron oxide particles.

Identifiers

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1216-2015%22

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