The Recall Desk
HighFDA (Drugs)·D-0732-2023·Announced 2023-05-31

FDA Recalls Heparin Injectable Due to Sterility Assurance Failure

Central Admixture Pharmacy Services is recalling 5,207 bags of heparin injectable nationwide due to an FDA-identified sterility assurance failure. The company cannot guarantee the sterility of affected lot numbers.

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: This is an FDA Class II recall involving a risk-of-harm injectable product with a sterility assurance failure. No illnesses or injuries have been reported, which qualifies as a high-risk product where injury has not yet been reported.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling 5,207 bags of heparin added to 0.9% sodium chloride injectable solution distributed nationwide. Each 500 mL bag contains 5,000 units of heparin (NDC 71285-7023-1).

The recall was initiated following an FDA inspection that raised questions about the sterility of the product. The manufacturer could not provide assurance that the affected lots met sterility requirements. For injectable medications, sterility is critical to patient safety.

The affected lot numbers are: 37-888736, 37-888769 (expires 05/02/2023); 37-890465, 37-890483 (expires 05/09/2023); 37-892088, 37-892117, 37-892119, 37-892145 (expires 05/16/2023); 37-893759, 37-893765 (expires 05/23/2023); and 37-895742, 37-895751 (expires 05/30/2023).

Healthcare providers and facilities should immediately cease use of the affected lots and contact their suppliers. Patients who may have received this medication should consult their healthcare provider about whether further medical evaluation is warranted.

The recalled product

Product
heparin added to 0.9% sodium chloride, 5,000 units/500 mL* (10 units/mL), 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7023-1.
Manufacturer
Central Admixture Pharmacy Services, Inc.
Category
Drug — Injectable / Sterile Product
Hazard
  • contamination-risk

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 (17)

  • Lot # 37-888736
  • 37-888769
  • Exp 05/02/2023
  • 37-890465
  • 37-890483
  • Exp 05/09/2023
  • 37-892088
  • 37-892117
  • 37-892119
  • 37-892145
  • Exp 05/16/2023
  • 37-893759
  • 37-893765
  • Exp 05/23/2023
  • 37-895742
  • 37-895751
  • Exp 05/30/2023

Distribution

Distributed nationwide across the United States.

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