SCA Pharmaceuticals Recalls Fentanyl and Bupivacaine Injection Due to Sterility Concerns
SCA Pharmaceuticals is recalling a specific lot of fentanyl and bupivacaine injection due to a lack of assurance of sterility and potential for leaking.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 infection or serious injury.
Plain-English summary
SCA Pharmaceuticals is voluntarily recalling a specific lot of fentanyl 3 mcg/mL + bupivacaine 0.1% in 0.9% Sodium Chloride 250 mL. 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 Lot 20170506@27 with a beyond-use date of 8/4/2017. The recall is classified as FDA Class II by the U.S. Food and Drug Administration.
Healthcare providers and patients should stop using the affected product and contact SCA Pharmaceuticals for further instructions.
The recalled product
- Product
- fentaNYL 3 mcg/mL + BUPIvacaine 0.1% in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0290-40
- 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 (1)
- Lot: 20170506@27 BUD: 8/4/2017
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.
See all 30 products in this recall →Related recalls
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