FDA Recalls Heparin IV Bags Due to Lack of Sterility Validation
Central Admixture Pharmacy Services is recalling 577 bags of heparin IV solution (2500 units/500mL) nationwide due to lack of validation data for sanitization cycles, which could compromise sterility assurance.
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 classification indicates a potentially serious hazard to a high-risk patient population (injectable product). However, the recall is based on lack of validation data rather than actual contamination or reported illnesses, which limits the score to 3 per the rubric.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling 577 bags of heparin added to 0.9% sodium chloride solution (2500 units/500mL IV bags) distributed nationwide. The affected product has lot numbers 36-260045 and 36-260046, with an expiration date of September 13, 2023 (NDC: 72196-8100-1).
The recall is issued by the FDA because the manufacturer lacks validation data for sanitization cycles used in the preparation of these IV bags. This raises concerns about the sterility assurance of the product. Heparin IV solutions must be sterile for injection into patients, and any compromise to sterility could pose serious health risks.
This product is a prescription medication distributed as part of hospital and pharmacy IV supplies. Patients and healthcare facilities with these lot numbers in stock should stop using the product immediately.
Healthcare providers should consult with affected patients and follow appropriate clinical protocols. The FDA recommends that affected facilities return the product to the manufacturer or dispose of it according to applicable regulations.
The recalled product
- Product
- heparin added to 0.9% sodium chloride, 2500 units/500mL (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.
- Category
- Drug — Injectable / IV Solution
- Affected units
- 577
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# 36-260045
- 36-260046
- Exp 9/13/2023.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 32 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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