Pharmedium Recalls ePHEDrine Sulfate Syringes Due to Stability Data Concerns
Pharmedium Services, LLC is recalling 1,545 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 the hazard is a potential loss of potency without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Pharmedium Services, LLC is recalling 1,545 syringes of ePHEDrine Sulfate, 10 mg per mL, in 0.9% Sodium Chloride, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Rx only. The product is identified by product code 2R3347. The recall is being conducted because stability data does not support the expiration dates for the drugs packaged and stored in syringes.
The affected lot numbers are 15118028M, 15118062M, 15125027M, 15126055M, 15131013M, 15133028M, 15139046M, 15146033M, 15146062M, 151880294M, 151890279M, 151930127M, and 151940261M. These lots have expiration dates between 07/15/15 and 10/12/15. The product was distributed nationwide.
The primary hazard is a potential loss of potency in the medication. Healthcare providers and patients should stop using the affected product and contact Pharmedium Services, LLC for further instructions or a replacement.
The recalled product
- Product
- ePHEDrine Sulfate, 10 mg per mL, in 0.9% Sodium Chloride, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3347.
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — Injectable
- Hazard
- Affected units
- 1,545
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 (14)
- Lot Numbers: 15118028M
- 15118062M
- 15125027M
- 15126055M
- 15131013M
- 15133028M
- 15139046M
- 15146033M
- 15146062M
- 151880294M
- 151890279M
- 151930127M
- 151940261M
- 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.
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