Heparin sodium chloride injection recalled nationwide due to sterility assurance questions
Central Admixture Pharmacy Services is recalling 1,300 bags of heparin injection nationwide after an FDA inspection questioned the product's sterility assurance.
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 an injectable product with critical safety requirements (sterility). No illnesses or injuries have been reported, making this a theoretical risk scenario. However, injectable medications require strict sterility, and assurance failures are inherently high-risk.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling heparin 2,500 units/250 mL added to 0.9% sodium chloride injection in 250 mL bags (NDC 71285-8000-1). The recall affects 1,300 bags distributed nationwide. Affected lot numbers are 37-888810 (Exp 05/02/2023), 37-892217 (Exp 05/16/2023), 37-895759 (Exp 05/30/2023), and 37-899174 (Exp 06/13/2023).
The recall was initiated after an FDA inspection questioned whether these products met sterility requirements. The company could not provide adequate assurance that proper sterilization controls were in place.
Healthcare facilities should identify and quarantine any remaining inventory of the recalled product. Patients who received injections from the recalled lots should consult their healthcare provider about their care.
The recalled product
- Product
- heparin added to 0.9% sodium chloride, 2,500 units/250 mL* (10 units/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-8000-1.
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Hazard
- sterility-assurance-failure
- 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 (8)
- Lot # 37-888810
- Exp 05/02/2023
- 37-892217
- Exp 05/16/2023
- 37-895759
- Exp 05/30/2023
- 37-899174
- Exp 06/13/2023
Distribution
Distributed nationwide across the United States.
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