The Recall Desk
SevereFDA (Drugs)·D-0038-2018·Announced 2017-11-01

Pharmedium Recalls Subpotent Oxytocin Injection Bags Nationwide

Pharmedium Services, LLC is voluntarily recalling Oxytocin 20 units in Lactated Ringer's Injection USP bags 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. According to the rubric, FDA Class II recalls with potential for significant injury or hospitalization (implied by subpotent drug status in a critical care setting) map to a score of 4 (Severe), as Class I is required for a score of 5.

Plain-English summary

Pharmedium Services, LLC is voluntarily recalling Oxytocin 20 units added to 1000 mL Lactated Ringer's Injection USP in 1000 mL bags. The recall was initiated because the product was found to be subpotent, meaning it contained less than the labeled amount of the active ingredient. The recall covers all unexpired lots of the product, which is identified by NDC# 71019-241-06.

The affected product was distributed nationwide. The recall was initiated on September 1, 2017, and was classified as Class II by the FDA. The recall status is currently terminated, with a termination date of January 24, 2020.

Healthcare providers and patients should stop using the affected product and contact Pharmedium Services, LLC for further instructions or replacement. The firm notified the public via a press release.

The recalled product

Product
Oxytocin 20 units added to 1000 mL Lactated Ringer's Injection USP in 1000 mL bag, Rx Only, Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130 Sugar Land, TX 77478, NDC# 71019-241-06

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 →