The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1081-2020·Announced 2020-04-15

PharMEDium Recalls ePHEDrine Sulfate Syringes Due to Sterility Concerns

PharMEDium Services is recalling 46 lots of ePHEDrine Sulfate syringes because the company could not ensure the products were sterile.

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 an intravenous product, which poses a significant risk of infection and potential hospitalization.

Plain-English summary

PharMEDium Services, LLC is recalling 46 lots of ePHEDrine Sulfate, 5 mg per mL, 50 mg per 10 mL, in 0.9% Sodium Chloride 10 mL syringes. The recall was initiated because the firm could not guarantee the sterility of the products.

The affected product is intended for intravenous use and is preservative-free. The recall covers 1,075 units that were distributed nationwide in the United States. Specific lot numbers and expiration dates are listed in the official recall documentation.

Healthcare providers and patients should stop using the recalled syringes and contact PharMEDium Services for further instructions. The FDA has classified this recall as Class II, indicating a reasonable probability that use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product
ePHEDrine Sulfate, 5 mg per mL, 50 mg per 10 mL, In 0.9% Sodium Chloride 10 mL syringe, For IV Use Preservative Free PharMEDium 913 N. Davis Ave. Cleveland, MS NDC 71030-003-12
Manufacturer
PharMEDium Services, LLC
Category
Drug — IV Solution
Hazard
Affected units
1,075

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 →

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