The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-0625-2020·Announced 2020-01-01

Pharmedium Recalls Subpotent Repinephrine Bitartrate Injection Bags

Pharmedium Services LLC is voluntarily recalling 5,820 bags of subpotent repinephrine bitartrate injection. The FDA classified this as a Class III recall.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this as a Class III recall, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.

Plain-English summary

Pharmedium Services LLC is voluntarily recalling 5,820 bags of NORepinephrine Bitartrate 8 mg added to 250 mL 5% Dextrose Injection USP. The product is a high-alert, prescription-only medication distributed nationwide in the United States. The recall was initiated because the drug was found to be subpotent, meaning it did not contain the full labeled amount of the active ingredient.

The FDA classified this recall as Class III, which indicates that use of or exposure to the violative product is not likely to cause adverse health consequences. The recall covers specific lots with expiration dates ranging from December 18, 2019, to January 30, 2020. The recall was initiated on December 16, 2019, and was terminated on February 9, 2021.

Healthcare providers and facilities that have received these products should stop using them and contact the recalling firm for instructions on return or disposal. Patients who have received this medication should consult their healthcare provider if they have questions about their treatment.

The recalled product

Product
NORepinephrine Bitartrate 8 mg added to 250 mL 5% Dextrose Injection USP (32 mcg per mL) Total Volume 258.00 mL Viaflex Bag, High Alert, Rx Only, PharMEDium Services LLC., 12620 W Airport Blvd #130 Sugar Land, TX 77478.
Manufacturer
Pharmedium Services, LLC
Category
Drug — Injection
Hazard
Affected units
5,820

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 (20)

  • Lot #s: 192930039S Exp. 12/18/19
  • 192930041S Exp. 12/18/19
  • 192940048S Exp. 12/19/19
  • 192940049S Exp. 12/19/19
  • 192950031S Exp. 12/20/19
  • 192950032S Exp. 12/20/19
  • 192960039S Exp. 12/22/19
  • 192960040S Exp. 12/22/19
  • 192960041S Exp. 12/22/19
  • 192960042S Exp. 12/22/19
  • 192970034S Exp. 12/22/19
  • 192970036S Exp. 12/22/19
  • 192970037S Exp. 12/22/19
  • 192980043S Exp. 12/25/19
  • 192980044S Exp. 12/25/19
  • 192980045S Exp. 12/25/19
  • 193010042S Exp. 12/26/19
  • 193020042S Exp. 12/27/19
  • 193030039S Exp. 12/28/19
  • 193030040S Exp. 12/28/19

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 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 3 products in this recall →

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