SCA Pharmaceuticals Recalls Fentanyl and Bupivacaine Infusion Bags for Sterility Concerns
SCA Pharmaceuticals is recalling specific lots of fentanyl and bupivacaine infusion bags 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, which corresponds to a Severe rating under the rubric due to the risk of serious, temporary, or medically reversible health consequences associated with non-sterile medical products.
Plain-English summary
SCA Pharmaceuticals is voluntarily recalling specific lots of fentanyl 2 mcg/mL and bupivacaine 0.0625% in 0.9% sodium chloride 250 mL infusion bags. 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 number 70004-0226-40. The specific lots subject to the recall are 20170429@29 with a best-use date of July 28, 2017, and 20170512@24 with a best-use date of August 10, 2017. The distribution pattern for these products is nationwide.
Healthcare providers and patients should check their inventory and medication records for these specific lot numbers. If the product is found, it should be discontinued and returned to the manufacturer or disposed of according to local regulations. Patients who have received this product should consult their healthcare provider if they have any concerns regarding their treatment.
The recalled product
- Product
- fentaNYL 2 mcg/mL+Bupivacaine 0.0625% PF in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 ---- NDC# 70004-0226-40
- Manufacturer
- SCA Pharmaceuticals
- Category
- Drug — Infusion Solution
- Hazard
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: 20170429@29 BUD: 7/28/2017
- 20170512@24 BUD: 8/10/2017
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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