CLASS III Drug recall · Reported 27 Feb 2019 · FDA Enforcement Report
Oxytocin added to NS (oxytocin recalled by Advanced Pharma
Advanced Pharma is recalling Oxytocin added to NS (oxytocin and 0.9% Sodium Chloride) Injectable Solution, distributed nationwide in the US. The recall was initiated on 6 Feb 2019 and the FDA has classified it as Class III.
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-0497-2019
- FDA event ID
- 82089
- Recalling firm
- Advanced Pharma, Houston, TX
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 6 Feb 2019
- FDA classified
- 15 Feb 2019
- Reported
- 27 Feb 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 6 Feb 2019 | Recall initiated by company | |
| 15 Feb 2019 | Classified by FDA | +9 days |
| 27 Feb 2019 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label.
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 10 Units added to NS 1000 mL (oxytocin and 0.9% Sodium Chloride) Injectable Solution, Approximately 1001 mL Sterile single use bag, Rx only, Avella of Houston, 9265 Kirby Dr., Houston, TX 77054, NDC 42852-730-99.
Where it was distributed
Nationwide in the USA.
Questions about this recall
Why was it recalled?
Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label.
Which lots are affected?
Lot: 12/20/18 1056 73099P, BUD: 02/03/2019
Where was it sold?
Nationwide in the USA.
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 82089This product is part of a recall event; the main page for the event is Oxytocin added to NS (oxytocin recalled by Advanced Pharma.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Oxytocin added to NS (oxytocin recalled by Advanced Pharma | Advanced Pharma | Potency & Assay | Nationwide | |
| CLASS III | Oxytocin added to NS (oxytocin recalled by Advanced Pharma | Advanced Pharma | Potency & Assay | Nationwide |
More recalls from Advanced Pharma
All 99| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | HYDROmorphone 20 mg/ Injectable Solution recalled by Advanced Pharma | Advanced Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Neostigmine Methylsulfate Injection Solution 5 mg recalled | Advanced Pharma | Sterility | Nationwide |
| Drug | CLASS II | Phenylephrine HCl, 1,200 mcg in 0.9% Sodium Chloride recalled | Advanced Pharma | Sterility | Nationwide |
| Drug | CLASS II | HYDROmorphone HCl 1 mg in 0.9% Sodium Chloride recalled | Advanced Pharma | Sterility | Nationwide |
| Drug | CLASS II | Heparin in 0.45% Sodium Chloride, QS, Injectable Solution recalled | Advanced Pharma | Sterility | Nationwide |