PharMEDium Recalls Bupivacaine Pumps Due to Incorrect Labeling
PharMEDium Services is recalling two Bupivacaine HCl ON-Q pumps due to incorrect or missing lot and expiration date labeling.
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 and labeling error.
Plain-English summary
PharMEDium Services, LLC is recalling two units of Bupivacaine HCl 0.25% 270 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chloride Injection. The recall was initiated because the product labels contained incorrect or missing lot and/or expiration dates.
The affected product is identified by NDC 61553-044-57 and Lot 170320107s. The expiration date on the label is listed as 01/01/1900. The recall covers a nationwide distribution of two I.V. pumps.
Healthcare providers and patients should stop using the affected product and contact PharMEDium Services for further instructions. This recall is classified as Class III by the FDA, indicating that the labeling error is unlikely to cause adverse health consequences.
The recalled product
- Product
- Bupivacaine HCl 0.25% 270 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chloride Injection in 270 mL, Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478, NDC: 61553-044-57
- Manufacturer
- Pharmedium Services Llc
- Category
- Drug — Compounded Injectable
- Hazard
- Affected units
- 2
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: 170320107s
- 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.
See all 7 products in this recall →Related recalls
Same manufacturer · Pharmedium Services Llc
See all →- SeverePharMEDium Recalls ePHEDrine Sulfate Syringes Due to Sterility Assurance Issues
FDA (Drugs) · 2020-04-15
- SeverePharMEDium Recalls nICARdipine HCl Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2020-04-15
- SeverePharMEDium Recalls Rocuronium Bromide Syringes Due to Sterility Assurance Issues
FDA (Drugs) · 2020-04-15
- SeverePharMEDium Recalls Rocuronium Bromide Syringes Due to Sterility Assurance Issues
FDA (Drugs) · 2020-04-15
- SeverePharMEDium Recalls Fentanyl Citrate Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2020-04-15
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02