The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-0627-2020·Announced 2020-01-01

Pharmedium Recalls Subpotent Repinephrine Bitartrate Injection Bags

Pharmedium Services LLC is recalling 5,808 bags of Repinephrine Bitartrate Injection due to subpotent drug levels. 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 recall as Class III, which by definition is unlikely to cause adverse health consequences, aligning with the 'Low' severity criteria for documentation or minor issues.

Plain-English summary

Pharmedium Services LLC is voluntarily recalling 5,808 bags of Repinephrine Bitartrate 4 mg added to 250 mL 5% Dextrose Injection USP. The product is identified as 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 contained less of the active ingredient than required.

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 19, 2020. The recall was initiated on December 16, 2019, and was terminated on February 9, 2021.

Healthcare providers and patients should check their inventory for the specific lot numbers listed in the recall notice. If you have this product, contact your healthcare provider or pharmacist for guidance on replacement or disposal. Do not use the recalled product until further notice.

The recalled product

Product
NORepinephrine Bitartrate 4 mg added to 250 mL 5% Dextrose Injection USP (16 mcg per mL) Total Volume 254.00 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 — Injectable
Hazard
Affected units
5,808

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)

  • Lots: 192930026S Exp. 12/18/19
  • 192950020S Exp. 12/20/19
  • 192960029S Exp. 12/21/19
  • 192970024S Exp. 12/22/19
  • 193010034S Exp. 12/26/19
  • 193030036S Exp. 12/28/19
  • 193040029S Exp. 12/29/19
  • 193050030S Exp. 1/1/20
  • 193080025S Exp. 1/2/20
  • 193080026S Exp. 1/2/20
  • 193080027S Exp. 1/2/20
  • 193090017S Exp. 1/3/20
  • 193090018S Exp. 1/3/20
  • 193100032S Exp. 1/4/20
  • 193120028S Exp. 1/8/20
  • 193160027S Exp. 1/10/20
  • 193170024S Exp. 1/11/20
  • 193170025S Exp. 1/11/20
  • 193180026S Exp. 1/12/20
  • 193190031S Exp. 1/15/20

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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