The Recall Desk
SevereFDA (Drugs)·D-1353-2015·Announced 2015-09-02

Pharmedium Recalls Oxytocin Injection Bags Due to Particulate Matter

Pharmedium Services, LLC is recalling 72 bags of oxyTOCIN 15 Units in 5% Dextrose Injection due to the presence of particulate matter.

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 classification is FDA Class I, which mandates a minimum severity score of 4 according to the rubric.

Plain-English summary

Pharmedium Services, LLC is voluntarily recalling 72 bags of oxyTOCIN 15 Units added to 250 mL 5% Dextrose Injection USP. The product is packaged in 250 mL bags and is available by prescription only. The specific lot number is 15041113S, with an expiration date of 04/23/15.

The recall was initiated because the products were produced using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP, which were subsequently recalled by the manufacturer due to the presence of particulate matter. The distribution of the affected product was nationwide.

Healthcare providers and consumers should stop using the affected product immediately. Patients who have received this product should contact their healthcare provider for further instructions.

The recalled product

Product
oxyTOCIN 15 Units added to 250 mL 5% Dextrose Injection USP, packaged in 250 mL bags, Rx only, PharMEDium Services, LLC, 12620 W Airport Blvd #130, Sugar Land, TX 77478, Service Code 2K2677, NDC# 61553-777-02.
Affected units
72

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 (2)

  • Lot #: 15041113S
  • Exp 04/23/15

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 6 recalled by Pharmedium Services, 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 6 products in this recall →