CLASS I Drug recall · Reported 26 Aug 2015 · FDA Enforcement Report
CARBOplatin Injection 450 mg/ (10 mg/mL) recalled by Mylan Institutional
Mylan Institutional is recalling CARBOplatin Injection 450 mg/ (10 mg/mL), distributed nationwide in the US. The recall was initiated on 18 Mar 2015 and the FDA has classified it as Class I.
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-1331-2015
- FDA event ID
- 70991
- Recalling firm
- Mylan Institutional, Rockford, IL
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 18 Mar 2015
- FDA classified
- 14 Aug 2015
- Reported
- 26 Aug 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 18 Mar 2015 | Recall initiated by company | |
| 14 Aug 2015 | Classified by FDA | +149 days |
| 26 Aug 2015 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Particulate Matter
Product as listed by the FDA
CARBOplatin Injection 450 mg/45 mL (10 mg/mL), 45 mL packaged in a 100 mL Multi-Dose Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103, Made in India, NDC 67457-493-46, UPC 3 67457 49346 6.
Where it was distributed
Nationwide
Questions about this recall
Is CARBOplatin Injection 450 mg/ (10 mg/mL) recalled?
Yes. Mylan Institutional recalled CARBOplatin Injection 450 mg/ (10 mg/mL) on 18 Mar 2015. The recall is Class I and its status is Terminated. Recall number D-1331-2015.
Why was it recalled?
Presence of Particulate Matter
Which lots are affected?
Lot #: 7801312, Exp 06/15
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 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 Mylan Institutional
All 24| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 150 mcg 15 mg) recalledLevothyroxine Sodium | Mylan Institutional | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 125 mcg 125 mg) recalledLevothyroxine Sodium | Mylan Institutional | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets recalled by Mylan InstitutionalLevothyroxine Sodium | Mylan Institutional | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets recalled by Mylan InstitutionalLevothyroxine Sodium | Mylan Institutional | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets recalled by Mylan InstitutionalLevothyroxine Sodium | Mylan Institutional | Potency & Assay | Nationwide |
Other Carboplatin recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | CARBOplatin Injection, 600 mg/, MultiDose recalled | Teva Pharmaceuticals USA | Sterility | 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 |
| Drug | CLASS III | Carboplatin Injection, 10 mg/mL, a) multi-dose vials recalled by HospiraCarboplatin | Hospira | Potency & Assay | Nationwide |