Mylan Institutional LLC
Product Description: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.
Status:Ongoing
City:Rockford
State:IL
Country:US
Voluntary/Mandated:Voluntary: Firm Initiated
Initial Firm Notification:Letter
Distribution Pattern:Nationwide and Puerto Rico
Classification:Class I
Product Quantity:a) 35,197 vials; b) 21,302 vials
Reason For Recall:Presence of Particulate Matter: visible foreign particulate matter observed during testing of retention samples.
Recall Initiation Date:20150323
Report Date:20150826
Mylan Institutional LLC
Product Description:Gemcitabine for Injection, USP, 1 g*/vial, Lyophilized powder in a Single-Use Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103, Made in India, NDC 67457-462-01, UPC 3 67457 46201 1.
Status:Ongoing
City:Rockford
State:IL
Country:US
Voluntary/Mandated:Voluntary: Firm Initiated
Initial Firm Notification:Letter
Distribution Pattern:Nationwide and Puerto Rico
Classification:Class I
Product Quantity:10,094 vials
Reason For Recall:Presence of Particulate Matter: visible foreign particulate matter observed during testing of retention samples.
Recall Initiation Date:20150323
Report Date:20150826

Gemcitabine Hydrochloride

Gemcitabine Hydrochloride

Gemcitabine Hydrochloride Recall

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Questions & Answers

Side Effects & Adverse Reactions

There is currently no warning information available for this product. We apologize for any inconvenience.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

1.1 Ovarian Cancer

Gemcitabine in combination with carboplatin is indicated for the treatment of patients with advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy.

1.2 Breast Cancer

Gemcitabine in combination with paclitaxel is indicated for the first-line treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated.

1.3 Non-Small Cell Lung Cancer

Gemcitabine is indicated in combination with cisplatin for the first-line treatment of patients with inoperable, locally advanced (Stage IIIA or IIIB), or metastatic (Stage IV) non-small cell lung cancer.

1.4 Pancreatic Cancer

Gemcitabine is indicated as first-line treatment for patients with locally advanced (nonresectable Stage II or Stage III) or metastatic (Stage IV) adenocarcinoma of the pancreas. Gemcitabine is indicated for patients previously treated with 5-FU.

History

There is currently no drug history available for this drug.

Other Information

Gemcitabine for injection USP is a nucleoside metabolic inhibitor that exhibits antitumor activity. Gemcitabine hydrochloride is 2´-deoxy-2´,2´-difluorocytidine monohydrochloride (    β-isomer).The structural formula is as follows:

structure

The empirical formula for gemcitabine hydrochloride is C9H11F2N3O4 • HCl. It has a molecular weight of 299.66.

Gemcitabine hydrochloride is a white to off-white solid. It is soluble in water, slightly soluble in methanol, and practically insoluble in ethanol and polar organic solvents.

Gemcitabine for injection USP is supplied in a sterile form for intravenous use only. Vials of Gemcitabine for Injection USP contain either 200 mg or 1 g of gemcitabine hydrochloride USP (expressed as free base) formulated with mannitol USP (200 mg or 1 g, respectively) and sodium acetate USP (12.5 mg or 62.5 mg, respectively) as a sterile lyophilized powder. Hydrochloric acid NF and/or sodium hydroxide NF may have been added for pH adjustment.

Gemcitabine Hydrochloride Manufacturers


  • Heritage Pharmaceuticals Inc.
    Gemcitabine Hydrochloride Injection, Powder, Lyophilized, For Solution [Heritage Pharmaceuticals Inc.]
  • Pfizer Laboratories Div Pfizer Inc.
    Gemcitabine Hydrochloride Injection, Powder, Lyophilized, For Solution [Pfizer Laboratories Div Pfizer Inc.]
  • Watson Laboratories, Inc.
    Gemcitabine Hydrochloride Injection, Powder, Lyophilized, For Solution [Watson Laboratories, Inc.]
  • App Pharmaceuticals, Llc
    Gemcitabine Hydrochloride Injection, Powder, Lyophilized, For Solution [App Pharmaceuticals, Llc]
  • App Pharmaceuticals, Llc
    Gemcitabine Hydrochloride (Gemcitabine) Injection, Powder, Lyophilized, For Solution [App Pharmaceuticals, Llc]
  • Teva Parenteral Medicines, Inc.
    Gemcitabine Hydrochloride Injection, Powder, Lyophilized, For Solution [Teva Parenteral Medicines, Inc.]
  • Hameln Rds Gmbh
    Gemcitabine Hydrochloride Injection, Powder, Lyophilized, For Solution [Hameln Rds Gmbh]
  • Mylan Institutional Llc
    Gemcitabine Hydrochloride Injection, Powder, Lyophilized, For Solution [Mylan Institutional Llc ]
  • Heritage Pharmaceuticals Inc.
    Gemcitabine Hydrochloride Injection, Powder, Lyophilized, For Solution [Heritage Pharmaceuticals Inc.]
  • Accord Healthcare Inc.
    Gemcitabine Hydrochloride Injection, Powder, Lyophilized, For Solution [Accord Healthcare Inc.]

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