The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-156-2013·Announced 2013-02-13

Bayer Recalls Leukine Sargramostim Vials Due to Impurities

Bayer HealthCare Pharmaceuticals is recalling Leukine sargramostim vials because a confirmed out-of-specification result for impurities was found in one lot.

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.

Plain-English summary

Bayer HealthCare Pharmaceuticals Inc. is recalling 138,505 vials of Leukine sargramostim 5 x 500 mcg/mL liquid injection. The recall is due to a confirmed out-of-specification result for impurities or degradation products in lot B18827, which was detected at the three-month time point.

The affected product is distributed nationwide. The recall includes vials with the following lot numbers and expiration dates: B18511 (Exp. 04/12), B18513 (Exp. 05/12), B18515 (Exp. 06/12), B18517 (Exp. 06/12), B18825 (Exp. 10/12), and B18831 (Exp. 12/12). The source text does not specify if other lots are affected, but the recall quantity covers the specified distribution.

Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the recalling firm for instructions on disposal or replacement. The FDA has classified this as a Class III recall, indicating that the violation is not likely to cause adverse health consequences.

The recalled product

Product
Leukine sargramostim 5 x 500 mcg/mL vial, liquid injection, Sterile Rx only, Mfd by: Bayer HealthCare Pharmaceuticals, LLC Seattle, WA 98101 U.S. Lic. No. 1791 NDC 58468-0181-2
Manufacturer
Bayer HealthCare Pharmaceuticals Inc.
Category
Drug — Injectable Medication
Hazard
Affected units
138,505

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 (6)

  • B18511 Exp. 04/12
  • B18513 Exp. 05/12
  • B18515 Exp. 06/12
  • B18517 Exp. 06/12
  • B18825 Exp. 10/12
  • B18831 Exp.12/12

Distribution

Distributed nationwide across the United States.

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