The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-0933-2017·Announced 2017-07-12

PharMEDium Recalls Ropivacaine Pumps Due to Incorrect Lot and Expiration Dates

PharMEDium Services, LLC is recalling 10 Ropivacaine HCl 0.2% ON-Q pumps nationwide due to incorrect or missing lot and expiration dates.

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/labeling error rather than a physical defect or contamination.

Plain-English summary

PharMEDium Services, LLC is recalling 10 units of Ropivacaine HCl 0.2% 750 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chloride Injection in 600 mL. The product is compounded by PharMEDium Services, LLC, located in Sugar Land, Texas, and carries the NDC 61553-279-33.

The recall was initiated because the product has incorrect or missing lot and/or expiration dates. The affected lot is identified as 170170204s, with an expiration date listed as 01/01/1900. The distribution pattern for these units is nationwide.

This is an FDA Class III recall, which indicates that the violation is not likely to cause adverse health consequences. Consumers and healthcare providers should stop using the affected product and contact PharMEDium Services, LLC for further instructions.

The recalled product

Product
Ropivacaine HCl 0.2% 750 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chloride Injection in 600 mL, Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478, NDC: 61553-279-33
Manufacturer
Pharmedium Services Llc
Category
Drug — Compounded Injectable
Hazard
Affected units
10

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: 170170204s
  • 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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