SCA Pharmaceuticals Recalls Fentanyl Syringes Due to Sterility Concerns
SCA Pharmaceuticals is recalling fentanyl citrate syringes 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 involves a sterile injectable drug with a risk of contamination (lack of sterility assurance) and physical defect (leaking), which poses a significant risk of harm.
Plain-English summary
SCA Pharmaceuticals is recalling fentanyl as citrate 5 mcg/mL in 0.9% Sodium Chloride 1 mL single-dose syringes. 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# 70004-0225-24, Lot 20170510@40, with a best-use date of 8/8/2017. The recall is classified as Class II by the FDA. The distribution pattern is listed as nationwide.
Healthcare providers and patients should stop using the affected syringes and contact SCA Pharmaceuticals or their healthcare provider for further instructions.
The recalled product
- Product
- fentaNYL as citrate 5 mcg/mL in 0.9% Sodium Chloride 1 mL in Single Dose syringe, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0225-24
- 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: 20170510@40 BUD: 8/8/2017
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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