PharMEDium Recalls Ropivacaine Pumps Due to Incorrect Labeling
PharMEDium Services is recalling 79 Ropivacaine HCl IV pumps 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 recall is classified as FDA Class III, which indicates a low risk of adverse health consequences, and the issue is limited to documentation and labeling errors.
Plain-English summary
PharMEDium Services, LLC is recalling 79 units of Ropivacaine HCl 0.2% 400 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chloride Injection. The recall is due to labeling errors where the lot and/or expiration date is incorrect or missing.
The affected product is a prescription-only compounded medication distributed nationwide. The specific lots involved are 170340164s and 170380152s, which are listed with an expiration date of 01/1/1900.
Consumers and healthcare providers should stop using the affected pumps and contact PharMEDium Services for further instructions or a return.
The recalled product
- Product
- Ropivacaine HCl 0.2% 400 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: 61553-256-09
- Manufacturer
- Pharmedium Services Llc
- Category
- Drug — Compounded Injectable
- Hazard
- Affected units
- 79
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: 170340164s Lot: 170380152s Ex.: 01/1/1900
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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