OxyTOCIN IV Bags Recalled for Lack of Sterility Validation
Central Admixture Pharmacy Services is recalling 298 bags of oxyTOCIN 40 units IV bags nationwide due to lack of validation data for sanitization cycles, creating potential sterility concerns.
What this means for you
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 injectable medication with unvalidated sterilization processes. While the hazard is theoretical with no reported illnesses or injuries, the risk of potential contamination in an IV product justifies a High severity rating.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling oxyTOCIN 40 units added to 0.9% sodium chloride 1000 mL intravenous (IV) bags due to lack of validation data for sanitization cycles. The recall affects 298 bags with lot number 36-260050, expiration date 10/3/2023, distributed nationwide.
The company could not provide adequate validation that its sanitization processes are effective at eliminating potential microbial contamination. Without this validation, the sterility assurance of these IV bags cannot be confirmed.
Healthcare providers and facilities that have received these IV bags should stop using them immediately. Check inventory using lot number 36-260050 and follow your organization's protocols for handling recalled products. If you have questions about the recall, contact Central Admixture Pharmacy Services, Inc.
The recalled product
- Product
- oxyTOCIN, 40 units added to 0.9% sodium chloride 1000 mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-8069-1
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Hazard
- sterility-assurance
- microbial-contamination
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# 36-260050
- Exp 10/3/2023.
Distribution
Distributed nationwide across the United States.
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