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Class II: temporary or reversible health riskTerminated

Caraco Pharmaceutical Laboratories Gemcitabine For Injection Recall

Gemcitabine For Injection USP, 1 g, (lyophilized), For Intravenous Use Only, Sterile Si…

Caraco Pharmaceutical Laboratories, Ltd. · Detroit, MI

Risk level
Class II
Reported by FDA
Jul 2, 2014
Recall ID
D-1407-2014
Check your lot numberHow we source this data

Summary

Caraco Pharmaceutical Laboratories recalled Gemcitabine For Injection starting Apr 9, 2014. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1407-2014 on Jul 2, 2014. Reason: Lack of Assurance of Sterility: A particle excursion for a different batch of the same product may lead to a lack of sterility assurance. Status: Terminated.

Why it was 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.

Product description

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

Lot numbers, UPCs & expiration codes

JKM7188A

Where it was sold

OH

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-1407-2014
Classification
Class II
Status
Terminated
Recall initiated
Apr 9, 2014
FDA report date
Jul 2, 2014
Quantity
200 vials
Recall type
Voluntary: Firm initiated
Recalling firm
Caraco Pharmaceutical Laboratories, Ltd.

Original FDA data

Every field from FDA enforcement report D-1407-2014, exactly as published.

Show all FDA fields
City
Detroit
State
MI
Status
Terminated
Country
United States
Event ID
68209
Address
1150 Elijah McCoy Dr
Code information
JKM7188A
Postal code
48202-3344
Report date
Jul 2, 2014
Product type
Drugs
Recall number
D-1407-2014
Classification
Class II
Recalling firm
Caraco Pharmaceutical Laboratories, Ltd.
Product quantity
200 vials
Termination date
Sep 29, 2014
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.
Voluntary / mandated
Voluntary: Firm initiated
Product description
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
Distribution pattern
OH
Recall initiation date
Apr 9, 2014
Initial firm notification
Telephone
Center classification date
Jun 20, 2014

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1407-2014, published Jul 2, 2014. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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