FDA Recalls Oxytocin IV Bags Due to Sterility Assurance Concerns
Central Admixture Pharmacy Services is recalling 463 bags of oxytocin IV solution nationwide due to inadequate validation data for sterilization processes. The product may not meet FDA sterility standards required for injectable medications.
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: This is an FDA Class II recall involving a sterility assurance issue with an injectable medication. The source text does not report any injuries or illnesses. Per the rubric, this qualifies as High severity (score 3) as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling oxytocin 20 units in dextrose 5%/lactated ringers solution in 1000 mL IV bags. The affected lot numbers are 36-249711 (expiration 8/20/2023), 36-250340 (expiration 8/23/2023), and 36-251645 (expiration 8/27/2023). Approximately 463 bags have been distributed nationwide in the USA.
The recall was initiated because the manufacturer lacks validation data for its decontamination cycles. This means the manufacturer cannot provide assurance that the product meets FDA sterility requirements for injectable medications.
Healthcare providers and patients with this medication should contact their pharmacy or healthcare provider immediately for further guidance.
The recalled product
- Product
- oxyTOCIN, 20 units added to dextrose 5%/lactated ringers 1000 mL, IV Bag, Rx Only, This drug was repacked by CAPS, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6031-1
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Affected units
- 463
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 (6)
- Lot: 36-249711
- Exp. 8/20/2023
- 36-250340
- Exp. 8/23/2023
- 36-251645
- Exp. 8/27/2023
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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