The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-0075-2018·Announced 2017-11-22

Genzyme Recalls Clolar Injection Due to Missing Package Insert

Genzyme Corporation is recalling Clolar (clofarabine) injection vials because the package insert is incorrect or missing.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this as a Class III recall, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The issue is a documentation/packaging defect (missing insert) rather than a direct safety hazard.

Plain-English summary

Genzyme Corporation is recalling 9,343 single-dose vials of Clolar (clofarabine) 20 mg/20 mL (1 mg/mL) Injection, for intravenous use. The recall was initiated because the product has an incorrect or missing package insert.

The affected product is manufactured by Teva Pharmachemie for Genzyme Corporation and is distributed nationwide. The recall includes vials from three specific lots: K5006Y01 (expiration 08/31/18), K5006Y03 (expiration 08/31/18), and K6001Y01 (expiration 03/31/19).

Healthcare providers and patients should check their inventory for these specific lot numbers and expiration dates. The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.

The recalled product

Product
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.
Manufacturer
Genzyme Corporation
Category
Drug — Antineoplastic
Hazard
Affected units
9,343

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

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

Distribution

Distributed nationwide across the United States.

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