Pharmedium Recalls ePHEDrine Sulfate Syringes Due to Stability Data Concerns
Pharmedium Services, LLC is recalling 1,478 syringes of ePHEDrine Sulfate because stability data does not support the expiration dates, posing a risk of reduced potency.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a potential loss of potency without reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
Pharmedium Services, LLC is recalling 1,478 syringes of ePHEDrine Sulfate, 10 mg per mL, 50 mg per 5 mL, in 0.9% Sodium Chloride, Preservative Free, 5 mL Total Volume in a syringe, For IV Use, Rx only, Product code 2R3308. The recall was initiated because stability data does not support the expiration dates for the product, which may result in a potential loss of potency in the drug.
The affected lot numbers are 15112085M, 15112087M, 15112090M, 15113020M, and 15113100M, with expiration dates ranging from 07/15/15 to 10/12/15. The product was distributed nationwide. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Healthcare providers and patients should stop using the affected syringes and contact Pharmedium Services, LLC for further instructions or a replacement. Patients should consult their healthcare provider regarding alternative treatments if necessary.
The recalled product
- Product
- ePHEDrine Sulfate, 10 mg per mL, 50 mg per 5 mL, in 0.9% Sodium Chloride, Preservative Free, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3308.
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — Injectable
- Hazard
- Affected units
- 1,478
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 (6)
- Lot Numbers: 15112085M
- 15112087M
- 15112090M
- 15113020M
- 15113100M
- Exp between 07/15/15-10/12/15
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 69 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 69 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 · loss of potency
See all →- ModerateInfuvite Adult Multiple Vitamins Injection Recalled Due to Cold Chain Failure
FDA (Drugs) · 2025-05-07
- ModerateCardinal Health Recalls Cyanocobalamin Injection Due to Temperature Excursions
FDA (Drugs) · 2021-06-02
- ModerateSmiths Medical Recalls Arterial Blood Sampling Kits with Povidone Iodine Pads
FDA (Devices) · 2019-02-27
- ModerateBiomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards Due to Moisture Risk
FDA (Devices) · 2017-06-21
- ModerateBiomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards
FDA (Devices) · 2017-06-21