PharMEDium Recalls ePHEDrine Sulfate IV Syringes Due to Sterility Concerns
PharMEDium Services is recalling 375 units of ePHEDrine Sulfate IV syringes because of a lack of sterility assurance.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II. According to the rubric, an FDA Class II recall involving a risk of harm (lack of sterility assurance in an IV product) where injury has not yet been reported falls under the 'Severe' category (Score 4), specifically aligning with the criterion for significant injury/property-damage reports or high-risk scenarios not yet resulting in reported illness but classified as Class II.
Plain-English summary
PharMEDium Services, LLC is recalling 375 units of ePHEDrine Sulfate, 5 mg per mL, 25 mg per 5 mL in 0.9% Sodium Chloride, 5 mL syringes. The product is intended for intravenous use and is preservative-free. The recall is being conducted because of a lack of sterility assurance.
The affected product is identified by NDC 71030-003-09, lot code 193500012D, and an expiration date of 3/16/2020. The recall notice indicates that the firm is recalling 46 lots of various products for this reason, though the specific distribution details for this particular ePHEDrine Sulfate lot are limited to the 375 units listed in the structured data.
Healthcare providers and patients should stop using the affected product and contact the manufacturer or their healthcare provider for further instructions. The FDA classifies this recall as Class II, indicating that use of or exposure to the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- ePHEDrine Sulfate, 5 mg per mL, 25 mg per 5 mL in 0.9% Sodium Chloride, 5 mL syringe, For IV use, Preservative Free, PharMEDium 913 W Davis Ave Cleveland MS 38732 NDC 71030-003-09
- Manufacturer
- PharMEDium Services, LLC
- Category
- Drug — IV Infusion
- Hazard
- Affected units
- 375
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)
- 193500012D
- Exp 3/16/2020
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 13 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 13 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 · lack of sterility
See all →- HighRohto Cooling Eye Drops Max Strength Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-07-29
- HighRohto Cooling Eye Drops Recalled Due to Lack of Assurance of Sterility
FDA (Drugs) · 2026-07-29
- SevereCleviprex Injectable Emulsion Recall Due to Sterility Assurance Concerns
FDA (Drugs) · 2026-07-22
- SeverePemetrexed for Injection recalled due to lack of sterility assurance
FDA (Drugs) · 2026-07-15
- SevereAzacitidine for Injection Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2026-07-15