FDA Drug recall D-0218-2017

Bupivacaine Hydrochloride Inj., USP (2.5 mg/mL) 0.25%, packaged in 30 mL Single-dose Preservative-Free vials, Rx Only, Hospira, Inc., Lake…

• FDA Drug
• Class I
• ongoing
• Published 2016-12-28

On 2016-12-28 the FDA classified a Class I recall of Bupivacaine Hydrochloride Inj., USP (2.5 mg/mL) 0.25%, packaged in 30 mL Single-dose Preservative-Free vials, Rx Only, Hospira, Inc., Lake… by Hospira A Pfizer, citing presence of particulate matter: Confirmed customer report for the presence of particulate matter within a single vial.

Read the official FDA Drug notice

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

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

Identifiers

Status history

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

Other recalls by Hospira A Pfizer

• Labetalol Hydrochloride Injection, USP, 100 mg/ 20 mL (5 mg/mL), 20 mL Multidose Vial, Rx only, labeled as a) Hospira, Inc., Lake Forest, I…
  FDA Drug · Class II · 2018-03-14 · Hospira A Pfizer
• Neut Sodium Bicarbonate 4% (2.4 mEq) Additive Solution 5 mL , a.) Single-dose vial (NDC 0409-6609-02), b.) 25 vial carton (NDC 0409-6609-25…
  FDA Drug · Class II · 2017-08-09 · Hospira A Pfizer
• Potassium Phosphates Inj., USP, 45 mM (3 mM P/mL) Also contains: 66 mEq K+ (4.4 mEq/mL) 15 mL, Single-dose, Caution: Must Be Diluted, Rx On…
  FDA Drug · Class II · 2017-08-09 · Hospira A Pfizer
• 8.4% Sodium Bicarbonate Inj., USP 50 mL Single-dose, 50 mEq (1 mEq/mL) 4.2 grams (84 mg/mL), Rx Only, Mfd by Hospira, INC, Lake Forest, IL…
  FDA Drug · Class II · 2017-08-09 · Hospira A Pfizer
• Succinylcholine Chloride Injection, USP 200 mg (20 mg/mL) Quelicin Multiple-dose vial, 10 mL, For I.V. or I.M. use. a.) one vial (NDC: 0409…
  FDA Drug · Class II · 2017-08-09 · Hospira A Pfizer

All Hospira A Pfizer recalls

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0218-2017%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.