NDC 0409-1160
Bupivacaine Hydrochloride 2.5 mg per 1 mL injection, solution
On the label: Hospira, Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Hospira, Inc. | Rocky Mount, NC, United States | Makes it, tests it, packages it and labels it | No problems foundFeb 7, 2025 · 11 inspections, 3 with FDA action |
| Pfizer Healthcare India Private Limited | Anakapalli, India | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilyOct 18, 2022 · 7 inspections, 1 with FDA action |
Recalls
- Apr 13, 2022 · Class II · Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Lots: McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer. - May 3, 2021 · Class I · Pfizer, Inc
Labeling: Label Mix-Up: some vials labeled to contain 0.5% Bupivacaine Hydrochloride Injection, USP may contain 1% Lidocaine HCl Injection, USP and some vials labeled to contain 1% Lidocaine HCl Injection, USP may contain 0.5% Bupivacaine Hydrochloride Injection, USP
Lots: Lot EG6023, Exp. 07/01/2022 - Aug 4, 2016 · Class I · Hospira Inc., A Pfizer Company
Presence of particulate matter: Confirmed customer report for the presence of particulate matter within a single vial.
Lots: Lot # 59064DK, Exp. 11/17 - Apr 23, 2015 · Class I · Hospira Inc.
Presence of Particulate Matter: Presence of free-floating and embedded iron oxide particles.
Lots: Lot #: 38-515-DK, Expiry: 1 FEB 2016. - Sep 4, 2014 · Class II · Hospira Inc.
Presence of Particulate Matter: A confirmed customer complaint reported the presence of a brown, rust-colored particle embedded at the bottom of the glass vial.
Lots: LOT 37-268-DK; Exp: 1JAN2016 - Feb 10, 2014 · Class II · Hospira Inc.
Presence of Particulate Matter: Confirmed customer report of visible particulate embedded in the glass vial.
Lots: Lot 25-097-DK; Exp 01/01/2015 - Oct 11, 2013 · Class II · Hospira Inc.
Lack of assurance of sterility; equipment failure led to potential breach in asceptic process.
Lots: Lot #32-484-EV, 32-485-EV Exp: 2/2015. - Sep 5, 2013 · Class II · Hospira Inc.
Lack of Assurance of Sterility; potential for vial breakage
Lots: Lot 17-400-EV* and 17-401-EV * Note: the lot number may be followed by 01 - Jul 12, 2013 · Class I · Hospira Inc.
Presence of particulate matter: visible free floating and partially embedded particulate matter in the glass vials.
Lots: Lot # 18-136-DK; Exp. 6/14 - Jul 12, 2013 · Class I · Hospira Inc.
Presence of particulate matter: visible free floating and partially embedded particulate matter in the glass vials.
Lots: Lot # 23-338-DK, Exp. 11/14
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Bupivacaine: every company that makes it
- Form
- injection, solution, infiltration; perineural
- Strength
- 2.5 mg per 1 mL
- Approval
- ANDA ANDA070590
- On the market since
- Apr 30, 2005
- Package NDCs
0409-1160-010409-1160-18- Official label
- DailyMed (National Library of Medicine), updated Mar 9, 2026
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