FDA Recalls OxyTOCIN IV Bags Due to Sterility Assurance Issues
Central Admixture Pharmacy Services is recalling 497 bags of OxyTOCIN IV bags nationwide due to lack of validated sterility assurance. The manufacturer's decontamination validation data is insufficient.
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 medication due to unvalidated sterilization process. No illnesses or injuries reported; hazard is theoretical based on lack of process validation.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling 497 bags of OxyTOCIN 30 units in dextrose 5%/lactated ringers 500 mL IV bags distributed nationwide.
The recall was initiated due to lack of assurance of sterility. The manufacturer lacks sufficient validation data for its decontamination cycles, meaning the sterilization process has not been properly verified to ensure the product is sterile.
The affected product includes Lot 36-249712 (expiration 8/20/2023) and Lot 36-250059 (expiration 8/22/2023), both with NDC 72196-6032-1. Healthcare facilities should check their inventory for these lots and take appropriate action in consultation with their pharmacy and medical leadership.
The recalled product
- Product
- oxyTOCIN 30 units added to dextrose 5%/lactated ringers 500 mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6032-1
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Intravenous
- Hazard
- Affected units
- 497
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 (4)
- Lot: 36-249712
- Exp. 8/20/2023
- 36-250059
- Exp. 8/22/2023
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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