Heparin intravenous bags recalled due to sterility assurance failure
Central Admixture Pharmacy Services is recalling 448 bags of heparin 7500 units in 0.9% sodium chloride IV solution due to lack of assurance of sterility. Validation data for decontamination cycles was not established.
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: The product is an intravenous medication with a sterility assurance failure due to missing validation data. While no illnesses have been reported, the lack of sterility assurance in an IV drug represents a significant contamination risk. This meets the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling heparin 7500 units added to 0.9% sodium chloride 1000 mL IV bags. The recalled product (lot numbers 36-256245 and 36-256249, expiring August 2023) was distributed nationwide. A total of 448 bags are affected.
The company issued this recall because it lacks assurance of the product's sterility. Specifically, validation data for the decontamination cycles is missing, meaning the manufacturer cannot confirm that the sterilization process was performed correctly.
For intravenous medications, sterility is essential to patient safety. Patients who may have received these bags should contact their healthcare provider. The full FDA recall notice should be consulted for additional details and instructions.
The recalled product
- Product
- heparin 7500 units added to 0.9% sodium chloride 1000mL, CONCENTRATION = 7.5 units/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-7009-1
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Intravenous
- Hazard
- Affected units
- 448
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 (2)
- Lot: 36-256245
- 36-256249 Exp. 8/23/2023.
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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