PharMEDium Recalls Ropivacaine HCl Injection Due to Labeling Errors
PharMEDium Services, LLC is recalling 21 pumps of Ropivacaine HCl 0.2% injection 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 FDA classified this recall as 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 hazard is limited to documentation and packaging issues.
Plain-English summary
PharMEDium Services, LLC is voluntarily recalling 21 I.V. pumps of Ropivacaine HCl 0.2% 550 mL Total Volume in an AutoFuser Pump in 0.9% Sodium Chloride Injection. The recall is being conducted because the product has incorrect or missing lot and/or expiration date labeling.
The affected product is identified by Lot 170310113s and an expiration date of 01/01/1900. The recall covers a nationwide distribution of the 21 units. The product is compounded by PharMEDium Services, LLC in Sugar Land, TX, and carries the NDC 61553-100-13.
The U.S. Food and Drug Administration has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences. Healthcare providers and patients should stop using the affected product and contact PharMEDium Services, LLC for further instructions.
The recalled product
- Product
- Ropivacaine HCl 0.2% 550 mL Total Volume in an AutoFuser Pump in 0.9% Sodium Chloride Injection, Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478, NDC: 61553-100-13
- Manufacturer
- Pharmedium Services Llc
- Category
- Drug — Injectable
- Hazard
- Affected units
- 21
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: 170310113s
- 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.
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