SCA Pharmaceuticals Recalls Fentanyl Infusion Bags Due to Sterility Concerns
SCA Pharmaceuticals is recalling specific lots of fentanyl infusion bags because they may leak and lack assurance of sterility.
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 classified this as a Class II recall. Per the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated as Severe (4).
Plain-English summary
SCA Pharmaceuticals is voluntarily recalling specific lots of fentanyl 10 mcg/mL in Sodium Chloride 250 mL infusion bags. The recall is being conducted because the product has the potential to leak and lacks assurance of sterility.
The affected product is prescription-only and was distributed nationwide. The specific lots involved are 20170509@20, 20170509@21, 20170509@46, and 20170511@33, all with expiration dates in August 2017.
Healthcare providers and patients should check their inventory and discontinue use of the affected lots. The FDA has classified this recall as Class II, indicating that use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- fentaNYL 10 mcg/mL PF in Sodium Chloride 250 mL (Total Dose=2500 mcg), Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0229-40
- Manufacturer
- SCA Pharmaceuticals
- Category
- Drug — Infusion Solution
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: 20170509@20 BUD: 8/7/2017
- 20170509@21 BUD: 8/7/2017
- 20170509@46 BUD: 8/7/2017
- 20170511@33 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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