NDC 0409-0525 – Marcaine
Bupivacaine Hydrochloride 250 mg/50mL · Injection, Solution · Perineural
Product NDC0409-0525
Product details
- Brand name
- Marcaine
- Generic name
- Bupivacaine Hydrochloride
- Labeler
- Hospira, Inc.
- Dosage form
- Injection, Solution
- Route
- Perineural
- Marketing category
- NDA · NDA016964
- Marketed since
- December 9, 2024
- Listing expires
- December 31, 2027
- Pharmacologic class
- Amide Local Anesthetic
Active ingredients
- Bupivacaine Hydrochloride 250 mg/50mL
Package NDC codes (1)
| Package NDC | Description | Since |
|---|---|---|
| 0409-0525-25 | 25 VIAL, MULTI-DOSE in 1 TRAY (0409-0525-25) / 50 mL in 1 VIAL, MULTI-DOSE (0409-0525-01) | Dec 9, 2024 |
Recalls mentioning this NDC
- D-0097-2017 Oct 19, 2016 · Class II
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… - D-0096-2017 Oct 19, 2016 · Class II
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… - D-0002-2015 Oct 8, 2014 · Class I
Presence of Particulate Matter: Confirmed customer complaint of discolored solution with visible metal particles embedded in the glass vial and visible in the solution. - D-1358-2014 Jun 11, 2014 · Class I
Presence of Particulate Matter: Confirmed customer complaint of discolored solution with visible metal particles embedded in the glass vial and visible in the solution. - D-1161-2014 Mar 26, 2014 · Class I
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.
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