SCA Pharmaceuticals Recalls NORepinephrine Injection Due to Sterility Concerns
SCA Pharmaceuticals is recalling NORepinephrine 4 mg in 0.9% Sodium Chloride 250 mL due to 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 rating under the rubric, particularly given the risk of infection from a lack of sterility assurance in an injectable drug.
Plain-English summary
SCA Pharmaceuticals is voluntarily recalling specific lots of NORepinephrine 4 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# 70004-0771-40. The recall covers lots 20170502@36, 20170512@1, 20170504@13, and 20170504@18. The distribution pattern for these products is nationwide.
Healthcare providers and patients should discontinue use of the affected lots and contact SCA Pharmaceuticals or their local FDA office for further instructions. Consumers should not use the product if it is found to be leaking or if sterility is in question.
The recalled product
- Product
- NORepinephrine 4 mg in 0.9% Sodium Chloride 250 mL from Stock, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0771-40
- Manufacturer
- SCA Pharmaceuticals
- Category
- Drug — Injectable
- Hazard
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 (4)
- Lots: 20170502@36 BUD: 7/31/2017
- 20170512@1 BUD: 8/10/2017
- 20170504@13 BUD: 8/2/2017
- 20170504@18 BUD: 8/2/2017
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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