Heparin IV bags recalled for lack of validated sterility assurance
Central Admixture Pharmacy Services is recalling 7,509 heparin IV bags nationwide because the company lacks validation data showing the sterilization process works. 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: This is an FDA Class II recall of intravenous heparin, a high-risk pharmaceutical product. Although no illnesses or injuries have been reported, the company cannot assure sterility due to missing validation data for decontamination cycles. This qualifies as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling 7,509 heparin IV bags distributed nationwide. Each bag contains 2500 units per 500 mL of heparin in 0.9% sodium chloride solution.
The FDA issued a Class II recall due to lack of assurance of sterility. The company does not have validation data for its decontamination cycles, meaning it cannot confirm that the product is free from microbial contamination. This represents a potential safety risk for patients receiving this medication.
The affected product includes multiple lot numbers with expiration dates ranging from July 11, 2023 to August 21, 2023. Heparin is used intravenously as an anticoagulant. Healthcare providers should immediately stop using affected lots and return them to the manufacturer.
To date, no illnesses or injuries have been reported in connection with this recall. Patients who have received affected lots should consult their healthcare provider if they have questions or concerns.
The recalled product
- Product
- heparin 2500 units/500mL added to 0.9% sodium chloride 5 units/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-8100-1
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Hazard
- unvalidated-sterilization
- 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 (20)
- Lot: 36-243815
- 36-243816
- Exp. 7/11/2023
- 36-247675
- 36-247676
- Exp. 7/20/2023
- 36-247837
- Exp. 7/21/2023
- 36-248988
- 36-248989
- Exp. 7/27/2023
- 36-249594
- 36-249595
- Exp. 7/29/2023
- 36-249833
- Exp. 8/1/2023
- 36-251054
- 36-251055
- 36-251056
- Exp. 8/4/2023
Distribution
Distributed nationwide across the United States.
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