CLASS II Drug recall · Reported 11 Sep 2013 · FDA Enforcement Report
CARBOplatin Injection, 600 mg/, MultiDose recalled
Teva Pharmaceuticals USA is recalling CARBOplatin Injection, 600 mg/, MultiDose, distributed nationwide in the US. The recall was initiated on 13 Aug 2013 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-928-2013
- FDA event ID
- 65959
- Recalling firm
- Teva Pharmaceuticals USA, Sellersville, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Aug 2013
- FDA classified
- 3 Sep 2013
- Reported
- 11 Sep 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 13 Aug 2013 | Recall initiated by company | |
| 3 Sep 2013 | Classified by FDA | +21 days |
| 11 Sep 2013 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility: The required reduction of endotoxin was not met during the annual revalidation of the vial washer.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
CARBOplatin Injection, 600 mg/60ml, MultiDose, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618 NDC 0703-3249-11
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility: The required reduction of endotoxin was not met during the annual revalidation of the vial washer.
Which lots are affected?
Lot 31314458B, 31314459B exp.08/14, 31315794 exp. 10/14, 31315982B exp.11/14
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Teva Pharmaceuticals USA
All 281| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Metoclopramide Tablets, USP, 5 mg, [100 or 500] Tablets recalledMetoclopramide | Teva Pharmaceuticals USA | Other | Nationwide |
| Drug | CLASS II | traZODone Hydrochloride Tablets, USP, 50 mg recalledTrazodone Hydrochloride | Teva Pharmaceuticals USA | Other | Nationwide |
| Drug | CLASS II | Octreotide Acetate for Injectable Suspension recalledOctreotide Acetate | Teva Pharmaceuticals USA | Sterility | Nationwide |
| Drug | CLASS II | Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) recalledClaravis | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Isotretinoin Capsules, USP, 30 mg recalled by Teva Pharmaceuticals USAIsotretinoin | Teva Pharmaceuticals USA | Potency & Assay | 4 states |
Other Carboplatin recalls
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Carboplatin 174 MG / Ns Ivpb recalled by Infusion Options | Infusion Options | Sterility | NY |
| Drug | CLASS I | CARBOplatin Injection 450 mg/ (10 mg/mL) recalled by Mylan Institutional | Mylan Institutional | Particulate Matter | Nationwide |
| Drug | CLASS I | Carboplatin Injection, 600 mg/ (10 mg/mL), Cytotoxic Agent recalledCarboplatin | Hospira | Particulate Matter | Nationwide |
| Drug | CLASS I | Carboplatin Injection, 450 mg/ (10 mg/mL), Cytotoxic Agent recalledCarboplatin | Hospira | Particulate Matter | Nationwide |
| Drug | CLASS II | Carboplatin Injection, 10 mg/mL Multi-Dose Vial recalled by HospiraCarboplatin | Hospira | Particulate Matter | Nationwide |