CLASS I Drug recall · Reported 19 Aug 2015 · FDA Enforcement Report
Cytarabine Injection 100 mg/ (20 mg/mL) Single-Dose Vial recalled
Mylan Institutional is recalling Cytarabine Injection 100 mg/ (20 mg/mL) Single-Dose Vial (, distributed nationwide in the US. The recall was initiated on 23 Apr 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-1329-2015
- FDA event ID
- 71079
- Recalling firm
- Mylan Institutional, Rockford, IL
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 23 Apr 2015
- FDA classified
- 13 Aug 2015
- Reported
- 19 Aug 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 23 Apr 2015 | Recall initiated by company | |
| 13 Aug 2015 | Classified by FDA | +112 days |
| 19 Aug 2015 | Published in enforcement report | +6 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
Cytarabine Injection 100 mg/5 mL (20 mg/mL), 5 mL Single-Dose Vial (NDC 0069-0152-01), packaged in 10 x 5 mL Vials per carton (NDC 0069-0152-02), Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc., New York, NY 10017.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Presence of Particulate Matter
Which lots are affected?
Lot # 7801050, Exp. Date. 05/2015
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 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 Mylan Institutional
All 24| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg) recalledLevothyroxine Sodium | Mylan Institutional | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg) recalledLevothyroxine Sodium | Mylan Institutional | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 137 mcg recalledLevothyroxine Sodium | Mylan Institutional | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 112 mcg recalledLevothyroxine Sodium | Mylan Institutional | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 150 mcg recalledLevothyroxine Sodium | Mylan Institutional | Potency & Assay | Nationwide |
Other Cytarabine recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Cytarabine 128 MG/ D5W IVPB recalled by Infusion Options | Infusion Options | Sterility | NY |
| Drug | CLASS II | CYTARAbine for Injection USP, lyophiled in glass vials per vial recalled | Ben Venue Laboratories | Sterility | Nationwide |
| Drug | CLASS II | Cytarabine Injection, 20 mg/mL Single Dose Vial recalled by Hospira | Hospira | Particulate Matter | Nationwide |