NDC 0409-1159 – Bupivacaine Hydrochloride
Bupivacaine Hydrochloride 2.5 mg/mL · Injection, Solution · Epidural, Infiltration, Intracaudal, Perineural
Product NDC0409-1159
Product details
- Brand name
- Bupivacaine Hydrochloride
- Generic name
- Bupivacaine Hydrochloride
- Labeler
- Hospira, Inc.
- Dosage form
- Injection, Solution
- Route
- Epidural, Infiltration, Intracaudal, Perineural
- Marketing category
- ANDA · ANDA070583
- Marketed since
- May 6, 2005
- Listing expires
- December 31, 2027
- Pharmacologic class
- Amide Local Anesthetic
Active ingredients
- Bupivacaine Hydrochloride 2.5 mg/mL
Uses, dosage, side effects and warnings for Bupivacaine Hydrochloride →
Package NDC codes (3)
| Package NDC | Description | Since |
|---|---|---|
| 0409-1159-01 | 25 VIAL, SINGLE-DOSE in 1 TRAY (0409-1159-01) / 10 mL in 1 VIAL, SINGLE-DOSE (0409-1159-18) | May 6, 2005 |
| 0409-1159-02 | 25 VIAL, SINGLE-DOSE in 1 TRAY (0409-1159-02) / 30 mL in 1 VIAL, SINGLE-DOSE (0409-1159-19) | Aug 15, 2005 |
| 0409-1159-10 | 25 VIAL, SINGLE-DOSE in 1 TRAY (0409-1159-10) / 30 mL in 1 VIAL, SINGLE-DOSE (0409-1159-09) | Aug 11, 2015 |
Recalls mentioning this NDC
- D-1095-2022 Jun 15, 2022 · Class II
cGMP deviations: Temperature abuse - D-0626-2021 Jun 9, 2021 · Class I
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… - D-0218-2017 Dec 28, 2016 · Class I
Presence of particulate matter: Confirmed customer report for the presence of particulate matter within a single vial. - D-1216-2015 Jul 15, 2015 · Class I
Presence of Particulate Matter: Presence of free-floating and embedded iron oxide particles. - D-1588-2014 Sep 24, 2014 · Class II
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. - D-1147-2014 Mar 12, 2014 · Class II
Presence of Particulate Matter: Confirmed customer report of visible particulate embedded in the glass vial. - D-395-2014 Jan 8, 2014 · Class II
Lack of assurance of sterility; equipment failure led to potential breach in asceptic process. - D-381-2014 Dec 25, 2013 · Class I
Presence of particulate matter: visible free floating and partially embedded particulate matter in the glass vials. - D-380-2014 Dec 25, 2013 · Class I
Presence of particulate matter: visible free floating and partially embedded particulate matter in the glass vials. - D-66295-001 Oct 16, 2013 · Class II
Lack of Assurance of Sterility; potential for vial breakage
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