CLASS II Drug recall · Reported 1 Nov 2017 · FDA Enforcement Report
Oxytocin added to Lactated Ringer's recalled by Pharmedium Services
Pharmedium Services is recalling Oxytocin added to Lactated Ringer's USP, distributed nationwide in the US. The recall was initiated on 1 Sep 2017 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0044-2018
- FDA event ID
- 78063
- Recalling firm
- Pharmedium Services, Lake Forest, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Sep 2017
- FDA classified
- 25 Oct 2017
- Reported
- 1 Nov 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 1 Sep 2017 | Recall initiated by company | |
| 25 Oct 2017 | Classified by FDA | +54 days |
| 1 Nov 2017 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent Drug
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Oxytocin 30 units added to 500 mL Lactated Ringer's USP in 500 mL bag Rx Only, Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130, Sugar Land, TX 77478, NDC# 71019-243-01
Where it was distributed
Nationwide.
Questions about this recall
Is Oxytocin added to Lactated Ringer's USP recalled?
Yes. Pharmedium Services recalled Oxytocin added to Lactated Ringer's USP on 1 Sep 2017. The recall is Class II and its status is Terminated. Recall number D-0044-2018.
Why was it recalled?
Subpotent Drug
Which lots are affected?
All unexpired lots.
Where was it sold?
Nationwide.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
| Drug | CLASS II | rocuronium Bromide, 10 mg per mL, 50 mg per BD Syringe recalled | PharMEDium Services | Sterility | Nationwide |
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