Heparin IV Bags Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling 5,834 bags of heparin 5000 units/500mL IV bags nationwide due to insufficient validation of sterilization processes, creating potential contamination risk.
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: This is an FDA Class II recall of an intravenous medication affecting sterility assurance—a high-risk product. No illnesses, injuries, or hospitalizations are reported in the source. Per the severity rubric, 'risk-of-harm products where injury has not yet been reported' receive a Score 3 (High).
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling 5,834 bags of heparin 5000 units/500mL added to 0.9% sodium chloride (10 units/mL, IV bags). The product carries NDC 72196-7023-1 and was distributed nationwide throughout the USA.
The recall was initiated because the manufacturer lacks sufficient validation data for decontamination cycles, preventing assurance that products meet required sterility standards for intravenous administration. Heparin is an anticoagulant medication administered intravenously in clinical settings. Non-sterile injectable medications pose serious health risks to patients, including potential bacterial contamination or other pathogens.
Affected lots include: 36-246161 (Exp. 7/14/2023); 36-247002, 36-247006, 36-247007 (Exp. 7/18/2023); 36-247673, 36-247674 (Exp. 7/20/2023); 36-247832, 36-247833, 36-247835, 36-247836 (Exp. 7/21/2023); 36-248991 (Exp. 7/27/2023); 36-249593 (Exp. 7/29/2023); 36-250046 (Exp. 8/2/2023); 36-251444, 36-251445, 36-251446, 36-251447 (Exp. 8/8/2023); 36-251968 (Exp. 8/10/2023); 36-254379, 36-254380 (Exp. 8/15/2023); and 36-254684 (Exp. 8/16/2023).
Healthcare facilities should immediately discontinue use of affected lots and quarantine remaining inventory. Consult with distributors and providers regarding proper handling and patient follow-up if doses were administered.
The recalled product
- Product
- heparin 5000 units/500mL added to 0.9% sodium chloride, 10 units/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-7023-1
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Intravenous Medication
- Affected units
- 5,834
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: 36-246161
- Exp. 7/14/2023
- 36-247002
- 36-247006
- 36-247007
- Exp. 7/18/2023
- 36-247673
- 36-247674
- Exp. 7/20/2023
- 36-247832
- 36-247833
- 36-247835
- 36-247836
- Exp. 7/21/2023
- 36-248991
- Exp. 7/27/2023
- 36-249593
- Exp. 7/29/2023
- 36-250046
- Exp. 8/2/2023
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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