Injectable Oxytocin Recalled Due to Unvalidated Sterilization Process
Central Admixture Pharmacy Services recalls oxytocin IV bags due to inadequate validation of sterilization, raising sterility concerns for this injectable.
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 for insufficient validation of sterilization in an injectable medication. The hazard is lack of sterility assurance without reported illness or confirmed harm, qualifying this as a risk-of-harm product.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling oxyTOCIN 30 units added to 0.9% sodium chloride in 500 mL IV bags. The recall affects 2,643 bags distributed nationwide due to lack of assured sterility caused by insufficient validation of the sanitization process.
The affected lot numbers are: 36-260031 and 36-260027 (expiration date 10/3/2023), and 36-262533, 36-262532, 36-262531, 36-262530, 36-262529, 36-262528, and 36-262527 (expiration date 10/9/2023).
The specific deficiency is the lack of validation data for sanitization cycles. Without proper validation of the sterilization process, there is no documented assurance that contamination has been eliminated from these injectable medications. This creates a potential risk to patients who received these products from the affected lot numbers.
The recalled product
- Product
- oxyTOCIN 30 units added to 0.9% sodium chloride 500 mL, IV Bag, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6044-1
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Injectable Medication
- Affected units
- 2,643
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 (11)
- Lot# 36-260031
- 36-260027
- Exp 10/3/2023
- 36-262533
- 36-262532
- 36-262531
- 36-262530
- 36-262529
- 36-262528
- 36-262527
- Exp 10/9/2023.
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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