SSM St. Clare Recalls Oxytocin IV Bags Due to Sterility Concerns
SSM St. Clare Health Center is recalling specific lots of compounded Oxytocin IV bags due to a lack of sterility assurance. No distributed product has been identified as actually containing microorganisms.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classifies this as an FDA Class II recall. Per the rubric, FDA Class II recalls with potential for adverse health consequences (such as sterility assurance failures in injectable drugs) are categorized as Severe (Score 4), as they are not Class I but involve significant risk.
Plain-English summary
SSM Health Care St. Louis DBA SSM St. Clare Health Center is recalling specific lots of Oxytocin 30 units in 0.9% Sodium Chloride 500 mL IV bags. The recall is due to a lack of sterility assurance, as microbial growth was detected during a routine simulation of the manufacturing process. The affected product is a compounded injectable drug intended for hospital or office use only.
The recall covers lots with the following expiration dates: 170619-011 (9/17/2017), 170707-007 (10/5/2017), and 170713-009 (10/11/2017). The product was distributed to SSM Health entities in the state of Missouri only. The agency has not identified any batches of distributed product as actually containing microorganisms.
Healthcare facilities and consumers should check their inventory for the specific lot numbers and expiration dates listed above. If the product is found, it should be quarantined and not used. The FDA classifies this recall as Class II, meaning there is a reasonable probability that the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Oxytocin 30 units in 0.9% Sodium Chloride 500 mL, 500 mL IV Bag, Concentration: 0.06 units/mL. This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO --- NDC: 88890-0903-01
- Category
- Drug — Compounded Injectable
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 (7)
- Lot
- exp: 170619-011
- 9/17/2017
- 170707-007
- 10/5/2017
- 170713-009
- 10/11/2017
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 10 recalled by SSM Health Care St. Louis DBA SSM St. Clare Health Center 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 10 products in this recall →Related recalls
Same manufacturer · SSM Health Care St. Louis DBA SSM St. Clare Health Center
See all →- HighPhenylephrine HCl Syringes Recalled for Sterility Assurance Failure
FDA (Drugs) · 2024-04-10
- HighInjectable Fentanyl Vials Recalled Due to Sterility Assurance Failure
FDA (Drugs) · 2024-04-10
- HighFDA Recalls Hydromorphone Injections Due to Discontinued Quality Assurance Program
FDA (Drugs) · 2023-06-07
- SeverePotassium Chloride Injection Recall Due to Sterility Assurance Lack
FDA (Drugs) · 2021-10-20
- ModerateSSM St. Clare Recalls Amiodarone Injectable Due to Sterility Concerns
FDA (Drugs) · 2018-01-03
Same hazard · sterility assurance
See all →- HighArrowhead DE LLC Recalls Arrow-LOK Implants Due to Sterility Assurance Concerns
FDA (Devices) · 2026-08-26
- SevereChloraPrep One-Step Applicators Recalled for Potential Packaging Seal Defects
FDA (Drugs) · 2026-07-22
- SeverePemetrexed for Injection Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2026-07-15
- SevereChloraPrep One-Step Applicators Recalled Due to Sterility Assurance Failure
FDA (Drugs) · 2026-07-08
- SevereArrow access trays and PSI kits contain recalled supplier drugs
FDA (Devices) · 2026-06-24