Agency classClass IIOur severity:High FDA (Drugs)·D-0972-2023·Announced 2023-08-09

FDA Recalls Oxytocin IV Bags for Sterility Assurance Issues

Central Admixture Pharmacy Services recalls 1,937 bags of oxytocin 10 units in Lactated Ringer's IV bags nationwide due to insufficient sterility assurance and missing validation data for decontamination cycles.

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 a critical injectable medication. The hazard—lack of sterility assurance in an intravenous product—represents a risk-of-harm scenario, and the source documentation contains no reports of injury, meeting the criterion for High severity.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling 1,937 bags of oxytocin 10 units added to Lactated Ringer's 500 mL IV bags (NDC 72196-6036-1) due to insufficient assurance of product sterility. The affected product was distributed nationwide across the United States.

The recall stems from a lack of assurance of sterility and missing validation data for decontamination cycles used in the manufacturing process. Oxytocin is a potent medication used in obstetric and gynecologic applications, and sterility is critical for intravenous medications.

The recall affects the following lot numbers and expiration dates: Lot 36-246733 (Exp. 7/12/2023); Lots 36-247777 and 36-247779 (Exp. 7/15/2023); Lot 36-250334 (Exp. 7/29/2023); Lots 36-251383 and 36-251384 (Exp. 8/2/2023); and Lot 36-251990 (Exp. 8/5/2023). Healthcare facilities and practitioners with this product should immediately quarantine it and contact Central Admixture Pharmacy Services for return instructions. Do not administer affected product to patients.

The recalled product

Product: oxyTOCIN 10 units added to Lactated Ringer's 500 mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6036-1
Manufacturer: Central Admixture Pharmacy Services, Inc.
Category: Drug — Intravenous Injection
Hazard: sterility-failure
inadequate-decontamination
Affected units: 1,937

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 (12)

Lot: 36-246733
Exp. 7/12/2023
36-247777
36-247779
Exp. 7/15/2023
36-250334
Exp. 7/29/2023
36-251383
36-251384
Exp. 8/2/2023
36-251990
Exp. 8/5/2023

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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Same hazard · sterility failure