PharMEDium Recalls Bupivacaine Pumps Due to Incorrect Labeling
PharMEDium Services is recalling seven Bupivacaine HCl ON-Q pumps 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 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.
Plain-English summary
PharMEDium Services, LLC is recalling seven units of Bupivacaine HCl 0.25% 400 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chloride Injection. The recall was initiated due to labeling errors, specifically incorrect or missing lot and expiration dates.
The affected product is identified by Lot 170300146s and an expiration date of 01/01/1900. The recall is classified as Class III by the FDA, indicating that use of or exposure to the product is not likely to cause adverse health consequences.
The product was distributed nationwide. Healthcare providers and patients should check their inventory for this specific lot and expiration date. If found, the product should be returned to the distributor or the recalling firm.
The recalled product
- Product
- Bupivacaine HCl 0.25% 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: 61553-023-09
- Manufacturer
- Pharmedium Services Llc
- Category
- Drug — Injectable
- Hazard
- Affected units
- 7
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: 170300146s
- 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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