The Recall Desk
HighFDA (Drugs)·D-0097-2023·Announced 2023-01-11

Heparin Sodium injectable bags recalled due to potential sterility assurance issues

Pfizer is recalling 62,088 bags of Heparin Sodium injection nationwide due to potential bag leakage that could compromise sterility. No illnesses have been reported.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II drug recall for Heparin Sodium with theoretical risk of sterility compromise due to potential bag leakage. Per the severity rubric, this qualifies as a risk-of-harm product where injury has not yet been reported, resulting in High severity.

Plain-English summary

Pfizer Inc. is recalling Heparin Sodium 2,000 USP Units per 1,000 mL in 0.9% Sodium Chloride Injection due to a lack of assurance of sterility. The bags have the potential to leak, which could compromise the sterility of the medication.

Approximately 62,088 bags of Lot 5935283 (expires 12/01/2023) were distributed nationwide in the USA.

No illnesses or injuries have been reported to date. Patients and healthcare providers who have received or used this product should contact Pfizer or their healthcare provider if they have questions. Healthcare facilities should identify and quarantine any remaining stock from the affected lot.

This is a Class II drug recall issued by the FDA.

The recalled product

Product
HEPARIN SODIUM (HEPARIN SODIUM)
Brand
HEPARIN SODIUM
Manufacturer
Pfizer Inc.
Category
Drug — Injectable
Hazard
  • leakage
  • contamination

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: 5935283
  • Exp. 12/01/2023

Distribution

Distributed nationwide across the United States.

Related recalls

Same brand · HEPARIN SODIUM

Same category