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

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

• sterility-assurance-failure

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Distributed nationwide across the United States.

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