NDC 61703-339 – Carboplatin
Carboplatin 10 mg/mL · Injection, Solution · Intravenous
Product NDC61703-339
Product details
- Brand name
- Carboplatin
- Generic name
- Carboplatin
- Labeler
- Hospira, Inc.
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Marketing category
- ANDA · ANDA076517
- Marketed since
- October 14, 2004
- Listing expires
- December 31, 2026
- Pharmacologic class
- Platinum-based Drug
Active ingredients
- Carboplatin 10 mg/mL
Package NDC codes (4)
| Package NDC | Description | Since |
|---|---|---|
| 61703-339-18 | 1 VIAL, MULTI-DOSE in 1 CARTON (61703-339-18) / 5 mL in 1 VIAL, MULTI-DOSE | Oct 14, 2004 |
| 61703-339-22 | 1 VIAL, MULTI-DOSE in 1 CARTON (61703-339-22) / 15 mL in 1 VIAL, MULTI-DOSE | Oct 14, 2004 |
| 61703-339-50 | 1 VIAL, MULTI-DOSE in 1 CARTON (61703-339-50) / 45 mL in 1 VIAL, MULTI-DOSE | Oct 14, 2004 |
| 61703-339-56 | 1 VIAL, MULTI-DOSE in 1 CARTON (61703-339-56) / 60 mL in 1 VIAL, MULTI-DOSE | Nov 23, 2004 |
Recalls mentioning this NDC
- D-154-2013 Feb 13, 2013 · Class I
Crystallization: Product is being recalled due to visible particulates identified during a retain sample inspection. Findings have identified the particles as Carboplatin crystals. - D-153-2013 Feb 13, 2013 · Class I
Crystallization: Product is being recalled due to visible particulates identified during a retain sample inspection. Findings have identified the particles as Carboplatin crystals. - D-1679-2012 Sep 26, 2012 · Class II
The affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, and Paclitaxel Injection are beig recalled due to visible particles embedded in the glass located at… - D-1648-2012 Aug 22, 2012 · Class III
Failed PH specification: The lots of Carboplatin Injection were manufactured from Carboplatin API lots which trended out of specification low pH.
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