PharMEDium Recalls Ropivacaine Pumps Due to Labeling Errors
PharMEDium Services is recalling 147 Ropivacaine HCl IV pumps nationwide because of 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 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. The issue is limited to documentation and labeling errors.
Plain-English summary
PharMEDium Services, LLC is recalling 147 units of Ropivacaine HCl 0.2% 500 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chloride Injection in 400 mL. The product is compounded by PharMEDium Services, LLC in Sugar Land, TX, and is distributed nationwide.
The recall was initiated due to labeling issues, specifically incorrect or missing lot and expiration dates. The affected lots are 170270192s, 170330167s, and 170320087s, with an expiration date listed as 01/01/1900.
Healthcare providers and patients should check their inventory for these specific lot numbers and stop using the product if the labeling is incorrect or missing. The FDA has classified this as a Class III recall, indicating that the labeling error is unlikely to cause adverse health consequences.
The recalled product
- Product
- Ropivacaine HCl 0.2% 500 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chloride Injection in 400 mL, Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478, NDC: 61553-258-25
- Manufacturer
- Pharmedium Services Llc
- Category
- Drug — Compounded Injectable
- Hazard
- Affected units
- 147
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)
- Lot: 170270192s Lot: 170330167s Lot: 170320087s Ex.: 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.
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