Genzyme Recalls Hectorol Injection Vials Due to Incorrect Barcode Labeling
Genzyme is recalling 2,350 vials of Hectorol (doxercalciferol) injection because the vial labels contain an incorrect barcode. The affected product was distributed to Michigan, Pennsylvania, and New Jersey.
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 recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The hazard is a minor labeling error (incorrect barcode) with no reported injuries or illnesses.
Plain-English summary
Genzyme Corporation is voluntarily recalling 2,350 vials of Hectorol (doxercalciferol injection) 2 mcg/1mL, a prescription-only medication. The recall was initiated because an incorrect barcode was identified on the vial labels. The affected product is identified by Lot # 6R1001 and has an expiration date of 12/2016.
The recalled product was distributed to Michigan, Pennsylvania, and New Jersey. Hectorol is a prescription medication manufactured by Genzyme Biosurgery Corporation. The recall is classified as Class III by the FDA, indicating that the labeling error is unlikely to cause adverse health consequences.
Healthcare providers and patients should stop using the affected vials and contact Genzyme for further instructions or a replacement. Consumers should verify the lot number and expiration date on their medication packaging to determine if they are affected.
The recalled product
- Product
- Hectorol (doxercalciferol injection) 2 mcg/1mL, Rx only, Manufactured by: Genzyme Biosurgery Corporation 500 Kendall Street, Cambridge, MA 02142, NDC 58468-0126-1
- Manufacturer
- Genzyme Corporation / Genzyme Biosurgery
- Category
- Drug — Injection
- Hazard
- Affected units
- 2,350
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 (2)
- Lot #: 6R1001
- Exp. 12/2016
Distribution
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