SCA Pharmaceuticals Recalls Phenylephrine Injection Due to Sterility Concerns
SCA Pharmaceuticals is recalling Phenylephrine 200 mg in 0.9% Sodium Chloride 250 mL injections 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, and the hazard involves a lack of assurance of sterility in an injectable medication, which poses a significant risk of serious injury or infection.
Plain-English summary
SCA Pharmaceuticals is recalling Phenylephrine 200 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 product is identified by NDC# 70004-0815-40, Lot 20170511@51, and has a beyond-use date of 8/9/2017. The distribution pattern for this recall is nationwide.
Healthcare providers and patients should discontinue use of the affected product. Consumers should contact their healthcare provider for further instructions or to obtain a replacement product if necessary.
The recalled product
- Product
- PHENYLephrine 200 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0815-40
- 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 (1)
- Lot: 20170511@51 BUD: 8/9/2017
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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