CLASS I Drug recall · Reported 26 Aug 2015 · FDA Enforcement Report
Gemcitabine for Injection, USP, 200 mg*/vial recalled
Mylan Institutional is recalling Gemcitabine for Injection, USP, 200 mg*/vial, Lyophilized powder in a Single-Use Vial, distributed nationwide in the US. The recall was initiated on 23 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-1332-2015
- FDA event ID
- 71004
- Recalling firm
- Mylan Institutional, Rockford, IL
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 23 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
| 23 Mar 2015 | Recall initiated by company | |
| 14 Aug 2015 | Classified by FDA | +144 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
Gemcitabine for Injection, USP, 200 mg*/vial, Lyophilized powder in a Single-Use Vial, Rx only, labeled as a) Manufactured for: Mylan Institutional LLC, Rockford, IL 61103, Made in India, NDC 67457-464-20, UPC 3 67457 46420 6; and b) Distributed by Pfizer Labs, Division of Pfizer Inc, New York, NY 10017, Made in India, NDC 0069-3857-10, UPC 3 00693 85710 4.
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Why was it recalled?
Presence of Particulate Matter
Which lots are affected?
Lot #: a) 7801396, 7801398, 7801401, 7801406, Exp 08/16; 7801427, Exp 09/16; b) 7801089, 7801084, Exp 07/15; 7801110, Exp 08/15
Where was it sold?
Nationwide and Puerto Rico
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.
Other products in this recall event
2 other products · FDA event 71004This product is part of a recall event; the main page for the event is Gemcitabine for Injection, USP*/vial, Lyophilized powder recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Gemcitabine for Injection, USP*/vial, Lyophilized powder recalled | Mylan Institutional | Particulate Matter | Nationwide | |
| CLASS I | Gemcitabine for Injection, USP*/vial, Lyophilized powder recalled | Mylan Institutional | Particulate Matter | Nationwide |
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 Gemcitabine recalls
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Gemcitabine Injection per (38 mg/mL) Single-Dose Vial recalledGemcitabine | McKesson | Temperature Abuse | Nationwide |
| Drug | CLASS II | Gemcitabine, Sterile Intravesical Solution recalled by Edge Pharma | Edge Pharma | Sterility | Nationwide |
| Drug | CLASS II | Gemcitabine Injection 200mg recalled by Cardinal Health | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |
| Drug | CLASS II | Gemcitabine 1910 MG / NS IVPB recalled by Infusion Options | Infusion Options | Sterility | NY |
| Drug | CLASS I | Gemcitabine for Injection, USP*/vial, Lyophilized powder recalled | Mylan Institutional | Particulate Matter | Nationwide |