Heparin IV Bags Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling 11,824 bags of heparin IV solution nationwide. The recall is due to lack of assurance of sterility and missing validation data for decontamination cycles.
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 an injectable product with documented deficiency in sterility assurance and decontamination validation. No reported illnesses or injuries. Meets criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling 11,824 bags of heparin IV solution distributed nationwide. The product is heparin 4000 units/1000mL added to 0.9% sodium chloride, supplied as a prescription injectable IV bag.
The recall was initiated due to a lack of assurance of sterility. The manufacturer lacks validation data for decontamination cycles, which is critical to confirm the product meets sterility standards.
The affected product includes multiple lot numbers with expiration dates ranging from July 10, 2023 to August 18, 2023. Healthcare facilities and patients who may have received this product should be aware of this recall.
The recalled product
- Product
- heparin 4000 units/1000mL added to 0.9% sodium chloride, 4 units/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-7022-1
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Injectable / IV Solution
- Hazard
- Affected units
- 11,824
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: 36-243555
- 36-243556
- Exp. 7/10/2023
- 36-245117
- 36-245118
- 36-245119
- 36-245120
- Exp. 7/12/2023
- 36-246163
- 36-246164
- Exp. 7/14/2023
- 36-247010
- Exp. 7/18/2023
- 36-248226
- 36-248229
- 36-248232
- 36-248248
- Exp. 7/24/2023
- 36-249829
- 36-249830
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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