Agency classClass IIOur severity:High FDA (Drugs)·D-0984-2023·Announced 2023-08-09

IV Oxytocin Solution Recall Due to Sterility Assurance Concerns

Central Admixture Pharmacy Services is recalling 9,504 IV bags of oxytocin mixed with Lactated Ringer's solution because validation data for sterilization cycles is lacking. The product was distributed nationwide.

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 of an injectable medication with no reported illnesses, injuries, or confirmed contamination—only validation data gaps. Per the rubric, risk-of-harm products without reported injury are scored at 3.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling oxytocin 20 units admixed with Lactated Ringer's 1000 mL intravenous bags (NDC 72196-6038-1). The product was manufactured and distributed nationwide.

The recall was initiated because validation data for decontamination cycles is lacking, creating uncertainty about whether sterilization processes were adequate to ensure the sterility of these injectable products.

The recall affects 9,504 IV bags distributed across multiple lot numbers with expiration dates ranging from July through August 2023.

Healthcare facilities and individuals should discontinue use of affected batches immediately. Contact your pharmacy or healthcare provider for guidance on affected lot numbers and replacement products.

The recalled product

Product: oxyTOCIN 20 units added to Lactated Ringer's 1000 mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6038-1
Manufacturer: Central Admixture Pharmacy Services, Inc.
Category: Drug — Injectable / IV Solution
Hazard: sterility
contamination-risk
Affected units: 9,504

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 (20)

Lot: 36-247256
36-247525
36-247259
Exp. 7/14/2023
36-247782
36-247784
Exp. 7/15/2023
36-247980
Exp. 7/16/2023
36-248274
36-248275
Exp. 7/19/2023
36-248732
36-248733
36-248734
36-248735
Exp. 7/21/2023
36-248971
36-248990
Exp. 7/22/2023

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.

See all 95 products in this recall →

Same manufacturer · Central Admixture Pharmacy Services, Inc.

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