CLASS II Drug recall · Reported 2 Jul 2014 · FDA Enforcement Report
Gemcitabine For Injection USP, (lyophilized) recalled
Caraco Pharmaceutical Laboratories is recalling Gemcitabine For Injection USP, (lyophilized), For Intravenous Use Only, Sterile Single, distributed in Ohio. The recall was initiated on 9 Apr 2014 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-1407-2014
- FDA event ID
- 68209
- Recalling firm
- Caraco Pharmaceutical Laboratories, Detroit, MI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Apr 2014
- FDA classified
- 20 Jun 2014
- Reported
- 2 Jul 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Lead & Heavy Metals
- Drug class
- Injectable & IV Drugs
Timeline
| 9 Apr 2014 | Recall initiated by company | |
| 20 Jun 2014 | Classified by FDA | +72 days |
| 2 Jul 2014 | 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
Lack of Assurance of Sterility: A particle excursion for a different batch of the same product may lead to a lack of sterility assurance.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
Gemcitabine For Injection USP, 1 g, (lyophilized), For Intravenous Use Only, Sterile Single Use Vial, Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd, Gujarat, India, NDC 47335-154-40
Where it was distributed
OH
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility: A particle excursion for a different batch of the same product may lead to a lack of sterility assurance.
Which lots are affected?
JKM7188A
Where was it sold?
OH
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 Caraco Pharmaceutical Laboratories
All 12Other 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 |