SCA Pharmaceuticals Recalls Fentanyl and Bupivacaine Injection Bags
SCA Pharmaceuticals is recalling 116 bags of fentanyl and bupivacaine injection due to a lack of assurance of sterility.
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 severity score under the rubric for significant injury or property damage reports.
Plain-English summary
SCA Pharmaceuticals, LLC is recalling 116 bags of fentanyl as citrate 2 mcg per mL and Bupivacaine HCl 0.125% in 0.9% Sodium Chloride. The product is identified by NDC 70004-0231-40, Lot 20170814@20, and a Beyond Use Date of 11/12/2017.
The recall was initiated because of a lack of assurance of sterility. The product was distributed nationwide in the United States.
Healthcare providers and patients should discontinue use of the affected product and contact SCA Pharmaceuticals for further instructions.
The recalled product
- Product
- fentanyl as citrate 2 mcg per mL BUPIvacaine HCl 0.125% (Total FentaNYL Dose 500 mcg/250 mL) in 0.9% Sodium Chloride 250 mL Bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205. NDC 70004-0231-40
- Manufacturer
- SCA Pharmaceuticals, LLC
- Category
- Drug — Injectable Anesthetic
- Hazard
- Affected units
- 116
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: 20170814@20 BUD: 11/12/2017
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 10 recalled by SCA Pharmaceuticals, LLC 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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