PharMEDium Recalls 46 Lots of IV Products Due to Sterility Concerns
PharMEDium Services, LLC is recalling 46 lots of various IV products because of a lack of sterility assurance. The products were distributed nationwide in the US.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 and involves a lack of sterility assurance in IV products, which poses a risk of significant injury or infection, meeting the criteria for a Severe rating.
Plain-English summary
PharMEDium Services, LLC is recalling 46 lots of various products because of a lack of sterility assurance. The recall includes ePHEDrine Sulfate 5 mg per mL 25 mg per 5 mL, in 0.9% Sodium Chloride, 5 mL BD Syringe, For IV Use, Rx Only, with NDC 71030-003-02.
The affected products were distributed nationwide in the US. The source text does not specify the total number of units recalled, specific lot numbers beyond the example provided, or the exact dates of distribution.
Consumers and healthcare providers should stop using the affected products and contact their pharmacist or the recalling firm for further instructions. 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.
The recalled product
- Product
- ePHEDrine Sulfate 5 mg per mL 25 mg per 5 mL, in 0.9% Sodium Chloride, 5 mL BD Syringe, For IV Use, Rx Only, PharMEDium 913 N. Davis Ave. Cleveland, MS 98732 NDC 71030-003-02
- Manufacturer
- PharMEDium Services, LLC
- Category
- Drug — IV Infusion
- Affected units
- 1,500
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)
- 193510031D
- Exp 3/17/2020
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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