SCA Pharmaceuticals Recalls Epinephrine HCl Due to Sterility Concerns
SCA Pharmaceuticals is recalling Epinephrine HCl 4 mg in 0.9% Sodium Chloride 250 mL due to a lack of assurance of sterility and potential for leaking.
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, which corresponds to a Severe severity score under the rubric for significant injury or property damage reports or high-risk scenarios.
Plain-English summary
SCA Pharmaceuticals is recalling Epinephrine HCl 4 mg in 0.9% Sodium Chloride 250 mL, a prescription-only medication. The recall is being conducted because the product has a lack of assurance of sterility and has the potential to leak.
The affected lots are 20170508@51 with a best use date of 9/10/2017, and 20170503@17 with a best use date of 9/5/2017. The product was distributed nationwide. The National Drug Code (NDC) for the product is 70004-0613-40.
Healthcare providers and patients should stop using the recalled product and contact SCA Pharmaceuticals or their healthcare provider for further instructions.
The recalled product
- Product
- EPINEPHrine HCl 4 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0613-40
- Manufacturer
- SCA Pharmaceuticals
- Category
- Drug — Injectable
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)
- Lots: 20170508@51 BUD: 9/10/2017
- 20170503@17 BUD: 9/5/2017
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 30 recalled by SCA Pharmaceuticals 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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