PillBupivacaine Hydrochloride
Brands: Bupivacine Hcl · Marcaine · Marvona Suik · Marvona-25 Suik +1 · Bupivacaine Hydrochloride
15 active makers
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Medicaid dispensing volumeSDUD · per quarter
Prescriptions dispensed under Medicaid (fee-for-service + managed care), summed nationally. The closest free proxy to sales volume — Medicaid only, not all-payer.
Who makes it15 active · 1 exited
US labelers as registered with FDA. Repackagers relabel another company's product; share* is of listed packages, not sales.
| Labeler | Type | Packages | Status |
|---|---|---|---|
| Hospira, Inc. | unknown | 14 | SUPPLYING |
| Camber Pharmaceuticals, Inc. | unknown | 13 | SUPPLYING |
| Fresenius Kabi USA, LLC | unknown | 12 | SUPPLYING |
| NorthStar RxLLC | unknown | 9 | SUPPLYING |
| Asclemed USA, Inc. | unknown | 6 | SUPPLYING |
| ONESOURCE SPECIALTY PHARMA LIMITED | unknown | 6 | SUPPLYING |
| Xellia Pharmaceuticals USA LLC | unknown | 6 | SUPPLYING |
| Hikma Pharmaceuticals USA Inc. | unknown | 6 | SUPPLYING |
| Eugia US LLC | unknown | 6 | SUPPLYING |
| Henry Schein Inc. | unknown | 3 | SUPPLYING |
| Fosun Pharma USA Inc | unknown | 2 | SUPPLYING |
| Anthea Pharma Private Limited | unknown | 2 | SUPPLYING |
| ProPharma Distribution | unknown | 2 | SUPPLYING |
| Sportpharm LLC | unknown | 2 | SUPPLYING |
| Cardinal Health 107, LLC | unknown | 1 | SUPPLYING |
+ 1 more labelers
Regulatory & supply eventsFDA · US
Shortages, recalls, and registration changes attached to this drug concept.
- Apr 13, 2022RECALLRecall (Class II): Bupivacaine Hydrochloride, USP 0.5% (5mg/mL), 25 vials x 50 mL per box, Rx only, MFG: Pfizer, NDC 0409-1163-01
cGMP deviations: Temperature abuse — Recalling firm: Mckesson Medical-Surgical Inc. Corporate Office — USA nationwide.
- Apr 13, 2022RECALLRecall (Class II): Bupivacaine HCl Injection, single dose vial, Preservative Free 0.5%, 10mL (25/ct), Rx only, Manufacturer: Auromedics Ph…
cGMP deviations: Temperature abuse — Recalling firm: Mckesson Medical-Surgical Inc. Corporate Office — USA nationwide.
- May 3, 2021RECALLRecall (Class I): 0.5% Bupivacaine Hydrochloride Injection, USP, 150 mg/30 mL (5 mg/mL), 30 mL Single-dose Teartop Vials (NDC 0409-1162-1…
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 — Recalling firm: PFIZER, INC — Nationwide in the USA, Puerto Rico, and Guam
- Feb 20, 2018SHORTAGEDrug shortage: Bupivacaine Hydrochloride Injection (ONESOURCE SPECIALTY PTE LTD)
Bupivacaine Hydrochloride Injection — reported in shortage by ONESOURCE SPECIALTY PTE LTD. Therapeutic category: Anesthesia.
- Feb 20, 2018SHORTAGEDrug shortage: Bupivacaine Hydrochloride Injection (Aspiro Pharma Limited)
Bupivacaine Hydrochloride Injection — reported in shortage by Aspiro Pharma Limited. Therapeutic category: Anesthesia.
- Feb 20, 2018SHORTAGEDrug shortage: Bupivacaine Hydrochloride Injection (Kindos Pharmaceuticals Co. Ltd.)
Bupivacaine Hydrochloride Injection — reported in shortage by Kindos Pharmaceuticals Co. Ltd.. Therapeutic category: Anesthesia.
- Feb 20, 2018SHORTAGEDrug shortage: Bupivacaine Hydrochloride, Epinephrine Bitartrate Injection (Hospira, Inc., a Pfizer Company)
Bupivacaine Hydrochloride, Epinephrine Bitartrate Injection — reported in shortage by Hospira, Inc., a Pfizer Company. Therapeutic category: Anesthesia.
- Feb 20, 2018SHORTAGEDrug shortage: Bupivacaine Hydrochloride Injection (Hospira, Inc., a Pfizer Company)
Bupivacaine Hydrochloride Injection — reported in shortage by Hospira, Inc., a Pfizer Company. Therapeutic category: Analgesia/Addiction, Anesthesia.
- Feb 20, 2018SHORTAGEDrug shortage: Bupivacaine Hydrochloride Injection (Eugia US LLC)
Bupivacaine Hydrochloride Injection — reported in shortage by Eugia US LLC. Therapeutic category: Anesthesia.
- Sep 16, 2016RECALLRecall (Class II): Marcaine 0.25% (bupivacaine HCl) injection, USP, 125 mg/50 mL (2.5 mg/mL), 50 mL Multiple-Dose Vial, Rx only, Hospira, …
Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from forming a seal allowing water to ingress and dilute the product causing it to be less than the labeled potency. — Recalling firm: Hospira Inc., A Pfizer Company — Nationwide and Puerto Rico
- Sep 16, 2016RECALLRecall (Class II): Marcaine 0.5% (bupivacaine HCl) injection, USP, 250 mg/50 mL (5 mg/mL), 50 mL Multiple-Dose Vial, Rx only, Hospira, Inc…
Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from forming a seal allowing water to ingress and dilute the product causing it to be less than the labeled potency. — Recalling firm: Hospira Inc., A Pfizer Company — Nationwide and Puerto Rico
- Aug 4, 2016RECALLRecall (Class I): Bupivacaine Hydrochloride Inj., USP (2.5 mg/mL) 0.25%, packaged in 30 mL Single-dose Preservative-Free vials, Rx Only, …
Presence of particulate matter: Confirmed customer report for the presence of particulate matter within a single vial. — Recalling firm: Hospira Inc., A Pfizer Company — Nationwide
- Apr 23, 2015RECALLRecall (Class I): Bupivacaine Hydrochloride Inj., USP, 0.5% (5 mg/mL), Preservative-Free, 30 mL Single Use Vials, Rx only. HOSPIRA, INC.…
Presence of Particulate Matter: Presence of free-floating and embedded iron oxide particles. — Recalling firm: Hospira Inc. — U.S. Nationwide including Guam.
- Sep 4, 2014RECALLRecall (Class II): Bupivacaine HCl Inj., USP, 0.5% (5 mg/mL), 30 mL Single-dose Preservative-Free, For Nerve Block, Caudal, and Epidural A…
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. — Recalling firm: Hospira Inc. — Nationwide
- Jun 17, 2014RECALLRecall (Class I): Marcaine (bupivacaine HCl) injection, USP, 0.5%, Preservative-Free, 30 mL (150 mg) Single-dose Vial, Rx only, Hospira, …
Presence of Particulate Matter: Confirmed customer complaint of discolored solution with visible metal particles embedded in the glass vial and visible in the solution. — Recalling firm: Hospira Inc. — Nationwide
- Apr 21, 2014RECALLRecall (Class I): Marcaine (bupivacaine HCl) injection, USP, 0.25%, Preservative-Free, 10 mL (25 mg) Single-dose Vial, Rx only, Hospira, …
Presence of Particulate Matter: Confirmed customer complaint of discolored solution with visible metal particles embedded in the glass vial and visible in the solution. — Recalling firm: Hospira Inc. — Nationwide.
- Feb 10, 2014RECALLRecall (Class II): Bupivacaine HCl Inj. USP, 0.5% (5 mg/mL), 30 mL Single-dose Preservative Free Vial, Rx Only, Hospira, Inc., Lake Forest…
Presence of Particulate Matter: Confirmed customer report of visible particulate embedded in the glass vial. — Recalling firm: Hospira Inc. — Nationwide
- Oct 18, 2013RECALLRecall (Class I): Marcaine (bupivacaine HCl) injection, USP, 0.25%, 30 mL single-dose vials-preservative free, packaged in 10-count vials…
Presence of Particulate Matter: Units of this lot may have visible metal particles embedded in the vial and in the solution causing the product to be discolored. — Recalling firm: Hospira Inc. — Nationwide
- Oct 11, 2013RECALLRecall (Class II): 0.5% Bupivacaine HCl and Epinephrine 1:200,000 Inj., 50 mL, Multiple-dose Fliptop Vial, Rx only, Hospira, Inc., Lake Fo…
Lack of assurance of sterility; equipment failure led to potential breach in asceptic process. — Recalling firm: Hospira Inc. — US Nationwide.
- Sep 5, 2013RECALLRecall (Class II): 0.5% Bupivacaine HCl and Epinephrine 1:200,000 Inj., 10 mL, Single-Dose Vial, NDC 0409-9045-01, Hospira, Inc., Lake For…
Lack of Assurance of Sterility; potential for vial breakage — Recalling firm: Hospira Inc. — Nationwide and Guam and Abu Dhabi
- Jul 12, 2013RECALLRecall (Class I): 0.25% Bupivacaine HCl Injection, USP, 2.5 mg/mL, 30 mL, Single-dose, Hospira Inc., Lake Forest, IL 60045, NDC 0409-1159…
Presence of particulate matter: visible free floating and partially embedded particulate matter in the glass vials. — Recalling firm: Hospira Inc. — Nationwide
- Jul 12, 2013RECALLRecall (Class I): 0.75% Bupivacaine HCl Injection, USP, 7.5 mg/mL, 30 mL, Single-dose, Hospira Inc., Lake Forest, IL 60045, NDC 0409-1165…
Presence of particulate matter: visible free floating and partially embedded particulate matter in the glass vials. — Recalling firm: Hospira Inc. — Nationwide