PharMEDium Recalls ePHEDrine Sulfate Syringes Due to Sterility Assurance Issues
PharMEDium Services is recalling 46 lots of ePHEDrine Sulfate syringes because of a lack of sterility assurance. The products were distributed nationwide in the US.
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 recall is classified as FDA Class II. The hazard involves a lack of sterility assurance in intravenous (IV) products, which poses a significant risk of serious injury or infection, fitting the criteria for a Severe rating.
Plain-English summary
PharMEDium Services, LLC is recalling 46 lots of ePHEDrine Sulfate 10 mg per mL 50 mg per 5 mL in 0.9% 5 mL Sodium Chloride 5 mL syringes. The recall is being conducted because of a lack of sterility assurance.
The affected products are prescription-only (Rx Only) and intended for intravenous (IV) use. The recall covers 900 units of the product. Specific lot codes identified in the notice include 193520006D (expiration 3/18/2020) and 193530009D (expiration 3/19/2020).
The products were distributed nationwide in the US. Patients and healthcare providers should stop using the recalled products and contact their healthcare provider or pharmacist for guidance on alternative treatments or returns.
The recalled product
- Product
- ePHEDrine Sulfate 10 mg per mL 50 mg per 5 mL in 0.9% 5 mL Sodium Chloride 5 mL syringe, For IV Use, Rx Only, PharMEDium 913 N Davis Avenue Cleveland, MS NDC 71030-001-09
- Manufacturer
- PharMEDium Services, LLC
- Category
- Drug — IV Injection
- Hazard
- Affected units
- 900
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 (1)
- 193520006D 3/18/2020 193530009D 3/19/2020
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.
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