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Class III: unlikely to cause harmTerminated

Genzyme Clolar Recall

Clolar (clofarabine) 20 mg/20 mL (1 mg/mL) Injection, for intravenous use, Rx Only, Mfd

Genzyme Corporation · Northborough, MA

Risk level
Class III
Reported by FDA
Nov 22, 2017
Recall ID
D-0075-2018
Check your lot numberHow we source this data

Summary

Genzyme recalled Clolar starting Oct 12, 2017. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0075-2018 on Nov 22, 2017. Reason: Labeling: Incorrect or Missing Package Insert. Status: Terminated.

Why it was recalled

Labeling: Incorrect or Missing Package Insert.

Product description

Clolar (clofarabine) 20 mg/20 mL (1 mg/mL) Injection, for intravenous use, Rx Only, Mfd. by: Teva Pharmachemie Swensweg 5 Haarlem, The Netherlands Mfd. for: Genzyme Corporation, Cambridge, MA 02142, NDC 0024-5860-01.

Lot numbers, UPCs & expiration codes

Lot #: K5006Y01; Exp. 08/31/18 Lot #: K5006Y03; Exp. 08/31/18 Lot #: K6001Y01; Exp. 03/31/19

Where it was sold

Nationwide

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-0075-2018
Classification
Class III
Status
Terminated
Recall initiated
Oct 12, 2017
FDA report date
Nov 22, 2017
Quantity
9,343 single dose vials
Recall type
Voluntary: Firm initiated
Recalling firm
Genzyme Corporation

Original FDA data

Every field from FDA enforcement report D-0075-2018, exactly as published.

Show all FDA fields
City
Northborough
State
MA
Status
Terminated
Country
United States
Event ID
78286
Address
11 Forbes Rd
Code information
Lot #: K5006Y01; Exp. 08/31/18 Lot #: K5006Y03; Exp. 08/31/18 Lot #: K6001Y01; Exp. 03/31/19
Postal code
01532-2501
Report date
Nov 22, 2017
Product type
Drugs
Recall number
D-0075-2018
Classification
Class III
Recalling firm
Genzyme Corporation
Product quantity
9,343 single dose vials
Termination date
Sep 10, 2020
Reason for recall
Labeling: Incorrect or Missing Package Insert.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Clolar (clofarabine) 20 mg/20 mL (1 mg/mL) Injection, for intravenous use, Rx Only, Mfd. by: Teva Pharmachemie Swensweg 5 Haarlem, The Netherlands Mfd. for: Genzyme Corporation, Cambridge, MA 02142, NDC 0024-5860-01.
Distribution pattern
Nationwide
Recall initiation date
Oct 12, 2017
Initial firm notification
Letter
Center classification date
Nov 10, 2017

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0075-2018, published Nov 22, 2017. View the source record (openFDA) · FDA enforcement reports

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

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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