The Recall Desk
HighFDA (Drugs)·D-0964-2022·Announced 2022-06-08

Oxytocin Injectable Drug Recalled for Lack of Sterility

Nephron Sterile Compounding Center has recalled 3,587 bags of Oxytocin injectable nationwide due to lack of assurance of sterility.

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: FDA Class II recall for lack of sterility assurance in an injectable drug. No reported illnesses or injuries in the source text, meeting the High severity criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Nephron Sterile Compounding Center LLC is recalling 3,587 bags of Oxytocin 30 Units/500 mL (0.06 Units/mL) in 0.9% Sodium Chloride Injection, USP, in 500 mL single-dose bags. The product has been distributed nationwide.

The recall is due to lack of assurance of sterility in the product. Non-sterile injectable solutions may pose a risk of contamination if used. The affected lot numbers are: OX2008C (expiring 5/27/2022), OX2010C (expiring 6/17/2022), OX2011C and OX2011D (expiring 6/24/2022).

Healthcare providers, pharmacists, and patients with this product should contact their healthcare provider immediately. Do not use product from the affected lots.

The recalled product

Product
Oxytocin 30 Units/500 mL (0.06 Units/mL) in 0.9% Sodium Chloride Injection, USP, 500 mL Single-Dose Container Bag, 10 x 1 IV Bag, 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
Hazard
Affected units
3,587

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)

  • Lots: OX2008C
  • Exp. 5/27/2022
  • OX2010C
  • Exp. 6/17/2022
  • OX2011C
  • OX2011D
  • Exp. 6/24/2022

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 20 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.

See all 20 products in this recall →

Related recalls

Same manufacturer · Nephron Sterile Compounding Center LLC

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Same hazard · sterility failure

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