Class I · High risk
Carboplatin Injection
Crystallization: Product is being recalled due to visible particulates identified during a retain sample inspection. Findings have identified the particles as Carboplatin crystals.
National Drug Code
Is NDC 61703-0360-18 recalled?
Carboplatin · 1 VIAL, MULTI-DOSE in 1 CARTON (61703-360-18) / 5 mL in 1 VIAL, MULTI-DOSE
Yes — this exact package was recalled
1 FDA recall names the code 61703-0360-18 directly. A recall still applies to particular lot numbers — compare the lot on your package with the FDA notice below, and talk to your pharmacist before stopping a prescribed medication.
- Active ingredient
- Carboplatin
- Strength
- CARBOPLATIN 10 mg/mL
- Form
- Injection, Solution · Intravenous
- Labeler
- Hospira, Inc.
- Type
- Human Prescription Drug
- Product code
- 61703-0360
Recalls naming this package
Class III · Low risk
Carboplatin Injection
Failed PH specification: The lots of Carboplatin Injection were manufactured from Carboplatin API lots which trended out of specification low pH.
Class II · Moderate risk
Carboplatin Injection
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 the neck of the vial. There may be the potential for product to come into contact with the embedded particles and the particles may become dislodged into the solution.
Where to find this code. The NDC is printed on the pharmacy label and on the manufacturer's carton, usually as three groups of digits after “NDC”. The last group is the package size — two bottles of the same medicine can differ only in that group, and a recall may cover one but not the other.
Other recalled products from this labeler
- 61703-0339 Carboplatin 4
- 61703-0303 Cytarabine 1
- 61703-0327 See recall 1
- 61703-0332 Bleomycin 1
- 61703-0342 Paclitaxel 1
- 61703-0343 Mitoxantrone 1
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