Heparin IV Bags Recalled Due to Sterility Assurance Failure
Central Admixture Pharmacy Services is recalling heparin IV bags due to lack of sterility assurance and missing validation data for decontamination cycles. The recall affects 358 bags distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 a high-risk injectable medication with lack of sterility assurance due to missing sterilization validation data. No illnesses or hospitalizations have been reported; the contamination risk is theoretical based on inadequate validation.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling heparin 2500 units in 0.9% sodium chloride 250mL IV bags because validation data for decontamination cycles is lacking. Without this data, the manufacturer cannot assure the sterility of these products.
The recalled lots are 36-249694 and 36-249695, both expiring July 31, 2023. A total of 358 bags were distributed nationwide to healthcare facilities and pharmacies.
Sterile injectable medications must be free from bacterial contamination to prevent patient harm. The absence of validation data means these specific IV bags may not have undergone adequate sterilization. Patients and healthcare providers who have received these products should contact the manufacturer or their healthcare provider if they have concerns.
The recalled product
- Product
- heparin 2500 units added to 0.9% sodium chloride 250mL, CONCENTRATION = 10 units/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-8000-1
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Injectable / IV
- Affected units
- 358
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 (3)
- Lot: 36-249694
- 36-249695
- Exp. 7/31/2023.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 95 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.
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