The Recall Desk
SevereFDA (Drugs)·D-0037-2018·Announced 2017-11-01

Pharmedium Recalls Subpotent Oxytocin Injection Bags Nationwide

Pharmedium Services, LLC is voluntarily recalling 2,232 bags of compounded Oxytocin injection because the drug was found to be subpotent.

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 recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for significant injury or health risk potential.

Plain-English summary

Pharmedium Services, LLC is voluntarily recalling 2,232 bags of Oxytocin 15 units added to 250 mL Lactated Ringer's Injection USP. The recall was initiated because the product was identified as a subpotent drug, meaning it may not contain the full amount of the active ingredient required for therapeutic effect.

The affected product is a prescription-only compounded medication distributed nationwide. The recall covers all unexpired lots of the product. The recall was initiated by the firm and is classified as FDA Class II.

Healthcare providers and patients should stop using the affected product and contact Pharmedium Services, LLC or their local FDA office for further instructions on returns or replacements.

The recalled product

Product
Oxytocin 15 units added to 250 mL Lactated Ringer's Injection USP in 250 mL bag, Rx Only, Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130, Sugar Land, TX 77478, NDC# 71019-239-01
Affected units
2,232

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 (1)

  • All unexpired lots.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 15 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 15 products in this recall →