Class II · Moderate risk
CARBOPLATIN 174 MG / 250ml NS IVPB
Lack of Assurance of Sterility
Carboplatin Injection
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed PH specification: The lots of Carboplatin Injection were manufactured from Carboplatin API lots which trended out of specification low pH.
Cause type: Failed specification
A physical or chemical test other than potency, dissolution, impurity or stability failed - pH, viscosity, appearance, tablet integrity, fill volume. A product outside its own specification may not perform as designed, even if the active ingredient is present. All failed specification recalls.
What was recalled
Carboplatin Injection, 10 mg/mL, a) 5 mL multi-dose vials (NDC 61703-339-18) (NDC 61703-360-18, NOVAPLUS), b) 45 mL multi-dose vials (NDC 61703-339-50) (NDC 61703-360-50 NOVAPLUS), Rx only, Hospira, Inc., Lake Forest, IL 60045, Product of Australia
Affected NDCs
61703-0339-18
61703-0339-50
61703-0360-18
61703-0360-50
Compare with the code on your package — it is the most precise check available.
Drug: Carboplatin
Product details
From the FDA NDC directory, for the product codes this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Carboplatin NDC 61703-0339 |
10 mg/mL | Injection, Solution Intravenous |
Hospira, Inc. | Rx |
| Carboplatin NDC 61703-0360 |
10 mg/mL | Injection, Solution Intravenous |
Hospira, Inc. | Rx |
- Recalling firm
- Hospira Inc.
- NDC code
- 61703-339-18
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1648-2012 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Carboplatin recalls
See all
Class I · High risk
CARBOplatin Injection 450 mg/45 mL
Presence of Particulate Matter
Class II · Moderate risk
Carboplatin active pharmaceutical ingredient packaged in varying…
Penicillin Cross Contamination: All lots of all products repackaged between 01/05/12 through 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk
CARBOplatin Injection
Lack of Assurance of Sterility: The required reduction of endotoxin was not met during the annual revalidation of the vial washer.
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.
Other recalls by Hospira Inc.
All 2012 recalls
Class I · High risk
Infant 25% DEXTROSE Injection
Presence of Particulate Matter: human hair found within an internal sample syringe.
Class II · Moderate risk
Fentanyl Citrate Injection
Lack of Assurance of Sterility: Complaints of broken tips on the ampules.
Class II · Moderate risk
DOBUTamine Injection
Discoloration: Firm received complaints of product discoloration and particulates.
Class III · Low risk
5% Lidocaine HCL and 7.5% Dextrose Injection
Failed Stability Specifications: The recalled lots did not meet the specification for color and pH throughout shelf life.
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