SCA Pharmaceuticals Recalls Fentanyl and Bupivacaine Infusion Bags Due to Sterility Concerns
SCA Pharmaceuticals is recalling specific lots of fentanyl and bupivacaine 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 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 voluntarily recalling fentanyl 2 mcg/mL + bupivacaine 0.125% PF in 0.9% Sodium Chloride 250 mL infusion bags. The recall is due to a lack of assurance of sterility and the potential for the product to leak.
The affected product is prescription-only and was distributed nationwide. The specific lots subject to the recall are 20170503@75 with a beyond-use date of August 1, 2017, and 20170511@21 with a beyond-use date of August 9, 2017.
Healthcare providers and patients should stop using the affected lots and contact SCA Pharmaceuticals or their local FDA office for further instructions on how to return or dispose of the product.
The recalled product
- Product
- fentaNYL 2 mcg/mL + BUPIvacaine 0.125% PF in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0254-40
- Manufacturer
- SCA Pharmaceuticals
- Category
- Drug — Injectable Medication
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: 20170503@75 BUD: 8/1/2017
- 20170511@21 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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