PharMEDium Recalls Ropivacaine Pumps Due to Labeling Errors
PharMEDium Services is recalling 22 Ropivacaine HCl pumps nationwide because of incorrect or missing lot and expiration dates.
What this means for you
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 indicates the product is not likely to cause adverse health consequences. The issue is limited to packaging and labeling errors.
Plain-English summary
PharMEDium Services, LLC is recalling 22 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 and distributed nationwide.
The recall was initiated due to labeling issues, specifically incorrect or missing lot and expiration dates. The affected lot number is 170340167s, and the expiration date is listed as 01/01/1900.
Healthcare providers and patients should stop using the affected product and contact PharMEDium Services for further instructions.
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: 61553-258-03
- Manufacturer
- Pharmedium Services Llc
- Category
- Drug — Compounded Injectable
- Hazard
- Affected units
- 22
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: 170340167s
- 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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