Oxytocin Injectable Recalled Due to Lack of Sterility Assurance
Nephron Sterile Compounding Center is recalling Oxytocin 30 Units/500 mL injectable solution due to lack of sterility assurance. Approximately 1,810 bags with lot codes OX2013C and OX2013E were distributed nationwide.
What this means for you
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 involving a risk-of-harm injectable medication with a lack of sterility assurance. The manufacturing hazard in an injectable product used in medical settings is significant. No adverse events are mentioned in the recall notice, aligning with the criteria for a High-severity (Score 3) rating.
Plain-English summary
Nephron Sterile Compounding Center LLC, a 503B outsourcing facility located at 4500 12th Street Extension, West Columbia, SC 29172, is recalling Oxytocin 30 Units/500 mL (0.06 Units/mL) in 0.9% Sodium Chloride Injection, USP supplied in IV bags. The product is packaged in cases of 10 individual 1 mL bags per case, with NDC 69374-543-50.
The recall was initiated due to lack of assurance of sterility in the manufactured product. Approximately 1,810 bags bearing lot numbers OX2013C and OX2013E, both with expiration date 7/9/2022, were distributed nationwide in the USA. This is an FDA Class II recall.
Oxytocin is a prescription injectable medication used in medical care. The affected lots have been recalled due to sterility assurance concerns. Holders of this product should refer to official FDA recall information for specific instructions on handling and disposition.
The recalled product
- Product
- Oxytocin 30 Units/500 mL (0.06 Units/mL) in 0.9% Sodium Chloride Injection, USP IV bag, packaged in 10 x 1 IV Bag per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-543-50
- Manufacturer
- Nephron Sterile Compounding Center LLC
- Category
- Drug — Injectable Medication
- Hazard
- Affected units
- 1,810
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 (3)
- Lots: OX2013C
- Exp. 7/9/2022
- OX2013E
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 37 recalled by Nephron Sterile Compounding Center LLC 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.
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