SCA Pharmaceuticals Recalls Repinephrine Bitartrate Due to Sterility Concerns
SCA Pharmaceuticals is recalling Repinephrine Bitartrate 16 mg in 0.9% Sodium Chloride 250 mL due to a lack of assurance of sterility and potential for product leakage.
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 FDA has classified this recall as Class II. According to the severity rubric, an FDA Class II recall involving a medication with sterility and leakage issues is categorized as Severe (Score 4), as it poses a risk of adverse health consequences.
Plain-English summary
SCA Pharmaceuticals is voluntarily recalling Repinephrine Bitartrate 16 mg in 0.9% Sodium Chloride 250 mL from Stock. The recall is being conducted because the product has a lack of assurance of sterility and has the potential to leak.
The affected product is prescription-only (Rx only) and is identified by NDC# 70004-0775-40. The recall includes specific lots with the following details: Lot 20170512@8 with a best use date of 8/10/2017, and Lot 20170506@18 with a best use date of 8/4/2017. The distribution pattern for this recall is nationwide.
Healthcare providers and patients should discontinue use of the affected lots and contact SCA Pharmaceuticals or their supplier for further instructions. The U.S. Food and Drug Administration (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
- NORepinephrine Bitartrate 16 mg in 0.9% Sodium Chloride 250 mL from Stock, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0775-40
- 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: 20170512@8 BUD: 8/10/2017
- 20170506@18 BUD: 8/4/2017
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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