The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-0935-2017·Announced 2017-07-12

PharMEDium Recalls Bupivacaine Pumps Due to Incorrect Labeling

PharMEDium Services is recalling two Bupivacaine HCl ON-Q pumps due to incorrect or missing lot and expiration date labeling.

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 recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The issue is a documentation and labeling error.

Plain-English summary

PharMEDium Services, LLC is recalling two units of Bupivacaine HCl 0.25% 270 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chloride Injection. The recall was initiated because the product labels contained incorrect or missing lot and/or expiration dates.

The affected product is identified by NDC 61553-044-57 and Lot 170320107s. The expiration date on the label is listed as 01/01/1900. The recall covers a nationwide distribution of two I.V. pumps.

Healthcare providers and patients should stop using the affected product and contact PharMEDium Services for further instructions. This recall is classified as Class III by the FDA, indicating that the labeling error is unlikely to cause adverse health consequences.

The recalled product

Product
Bupivacaine HCl 0.25% 270 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chloride Injection in 270 mL, Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478, NDC: 61553-044-57
Manufacturer
Pharmedium Services Llc
Category
Drug — Compounded Injectable
Hazard
Affected units
2

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: 170320107s
  • Exp. 01/01/1900

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 7 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 7 products in this recall →

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