Amide Local Anesthetic, Catecholamine
Where is Bupivacaine and Epinephrine made?
3 companies sell it under their own name and 4 repackagers rebottle it. Their labels name 4 factories in the United States and Canada.
United States 3Canada 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Hospira, Inc. Marcaine with Epinephrine2.5 mg per 1 mL / 0.0091 mg per 1 mL, 5 mg per 1 mL / 0.0091 mg per 1 mL, 5 mg per 1 mL / 5 ug per 1 mL, 5 ug per 1 mL / 2.5 mg per 1 mL · NDC 0409-5738, 0409-3812, 0409-1541 +11 | Hospira, Inc.Makes it, tests it, packages it and labels it | Rocky Mount, NC, United States | No problems foundFeb 2025 |
| Hospira, Inc.Makes it, tests it, packages it and labels it | McPherson, KS, United States | Problems found, fixed voluntarilyJan 2025 | |
| Fresenius Kabi, LLC Sensorcaine Mpf2.5 mg per 1 mL / 0.005 mg per 1 mL, 5 mg per 1 mL / 0.005 mg per 1 mL, 7.5 mg per 1 mL / 0.005 mg per 1 mL · NDC 63323-461, 63323-468, 63323-463 +2 | Fresenius Kabi USA, LLCMakes it and tests it | Melrose Park, IL, United States | Problems found, fixed voluntarilyAug 2023 |
| Septodont, Inc.5 mg per 1 mL / 0.005 mg per 1 mL · NDC 0362-0557, 0362-9011 | Novocol Pharmaceutical of Canada, Inc.Makes it | Cambridge, Canada | Problems found, fixed voluntarilyMay 2024 |
Repackaged by
These companies buy Bupivacaine and Epinephrine in bulk and rebottle it, often for mail-order, clinic or hospital pharmacies. If your bottle shows one of these names, open its NDC to see who made the pills inside.
- HF Acquisition Co. LLC. DBA HealthFirst:
51662-1397,51662-1399 - Henry Schein, Inc.:
0404-9908,0404-9828 - Physicians Total Care, Inc.:
54868-3438,54868-3439 - Sportpharm LLC:
85766-255
Recalls
- Nov 22, 2022 · Class II · Fresenius Kabi USA, LLC · 3 recall notices
Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product. - Apr 13, 2022 · Class II · Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse - 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 Inject… - Dec 10, 2020 · Class II · Fresenius Kabi USA, LLC
Subpotent Drug: Low out-of-specification assay results for the epinephrine component. - 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. - Apr 25, 2016 · Class II · Fresenius Kabi USA, LLC
Presence of Particulate Matter: Glass particulate found in sterile injectable product - Apr 23, 2015 · Class I · Hospira Inc.
Presence of Particulate Matter: Presence of free-floating and embedded iron oxide particles. - 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. - Feb 10, 2014 · Class II · Hospira Inc.
Presence of Particulate Matter: Confirmed customer report of visible particulate embedded in the glass vial. - Oct 11, 2013 · Class II · Hospira Inc.
Lack of assurance of sterility; equipment failure led to potential breach in asceptic process. - Sep 5, 2013 · Class II · Hospira Inc.
Lack of Assurance of Sterility; potential for vial breakage - Jul 12, 2013 · Class I · Hospira Inc. · 2 recall notices
Presence of particulate matter: visible free floating and partially embedded particulate matter in the glass vials.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.