The Recall Desk
HighFDA (Drugs)·D-0726-2023·Announced 2023-05-31

FDA Recalls Heparin-Sodium Chloride Injection Nationwide for Sterility Assurance Failure

Central Admixture Pharmacy Services is recalling 3,055 bags of heparin injection nationwide due to sterility assurance concerns identified during FDA inspection. Healthcare providers and patients should discontinue use of affected lots.

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 recall of injectable medication with no reported illnesses or injuries. Per the rubric, risk-of-harm products where injury has not yet been reported score as High (3), capped at this level due to absence of confirmed contamination or reported harm.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling 3,055 bags of heparin added to 0.9% sodium chloride injection. The product is a 1,000 mL bag containing 7.5 units per milliliter of heparin (NDC 71285-7009-1), distributed nationwide in the United States.

An FDA inspection called into question the sterility assurance of these injectable products, leading to the recall. Lack of assured sterility in injectable medications poses a potential risk to patient safety, as contaminated products could cause infections or other serious health effects.

Healthcare providers and patients should discontinue use of affected lot numbers and consult their healthcare provider if they have already received this product. The recalled lot numbers are 37-888668, 37-888685, 37-888701 (expiring 05/02/2023); 37-890550, 37-890556 (expiring 05/09/2023); 37-892201, 37-892216 (expiring 05/16/2023); 37-893866, 37-893917, 37-893918 (expiring 05/23/2023); and 37-895705, 37-895717 (expiring 05/30/2023).

The recalled product

Product
heparin added to 0.9% sodium chloride, 7,500 units/1,000 mL* (7.5 units/mL), 1000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7009-1.
Manufacturer
Central Admixture Pharmacy Services, Inc.
Category
Drug — Injectable Medication
Hazard
Affected units
3,055

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 # 37-888668
  • 37-888685
  • 37-888701
  • Exp 05/02/2023
  • 37-890550
  • 37-890556
  • Exp 05/09/2023
  • 37-892201
  • 37-892216
  • Exp 05/16/2023
  • 37-893866
  • 37-893917
  • 37-893918
  • Exp 05/23/2023
  • 37-895705
  • 37-895717
  • Exp 05/30/2023

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 108 recalled by Central Admixture Pharmacy Services, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 108 products in this recall →

Related recalls

Same manufacturer · Central Admixture Pharmacy Services, Inc.

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Same hazard · sterility assurance failure

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