Fentanyl-Bupivacaine Epidural Injection Recalled for Sterility Assurance Failure
SCA Pharmaceuticals is recalling 242 bags of fentanyl-bupivacaine epidural injection due to lack of assurance of sterility. The affected lot may not meet required sterility standards.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for lack of sterility assurance on an injectable drug for epidural administration. This is a risk-of-harm product; sterility failures on injectable drugs can result in serious infection if contamination has occurred.
Plain-English summary
SCA Pharmaceuticals, LLC is recalling a specific lot of fentanyl-bupivacaine epidural injection due to a lack of assurance of sterility. The recalled product contains fentanyl 200 mcg/100 mL combined with bupivacaine HCl 0.125% in 0.9% sodium chloride, supplied in 100 mL bags for epidural use only.
The recall affects 242 bags of Lot #1223048855 with expiration date 12/6/23, distributed nationwide in the United States. The manufacturer could not assure that the product meets required sterility standards.
Patients and healthcare providers should not use this specific lot. Any patients who have received injections from this lot should inform their healthcare provider. Healthcare facilities should segregate any remaining inventory and contact their supplier for recall procedures.
The recalled product
- Product
- fentaNYL 200 mcg/100 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL Concentration = 2 mcg/mL), EPIDURAL USE ONLY, 100 mL Bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0231-32, Bar Code 70004023132
- Manufacturer
- SCA Pharmaceuticals, LLC
- Category
- Drug — Injectable Anesthetic
- Affected units
- 242
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)
- Lot #: 1223048855
- Exp 12/6/23
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 32 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.
See all 32 products in this recall →Related recalls
Same manufacturer · SCA Pharmaceuticals, LLC
See all →- HighPhenylephrine HCl Injections Recalled Nationwide for Sterility Assurance Issues
FDA (Drugs) · 2024-04-03
- HighInjectable midazolam HCl recalled due to sterility assurance failure
FDA (Drugs) · 2024-04-03
- HighFentanyl and Bupivacaine Epidural Injection Recalled for Sterility Assurance Issue
FDA (Drugs) · 2024-04-03
- HighHydromorphone Injection Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2024-04-03
- HighHYDROmorphone HCl 6 mg Injectable Syringes Recalled Due to Sterility Assurance Issues
FDA (Drugs) · 2024-04-03
Same hazard · sterility failure
See all →- SevereAvKare Carboxymethylcellulose Sodium Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereAvKare Carboxymethylcellulose Sodium Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereROHTO DIGI-EYE Eye Drops Recalled Over Sterility Assurance Gap
FDA (Drugs) · 2026-07-29
- HighROHTO DRY-AID Eye Drops Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-07-29
- SevereOne-Piece Introducer Tray kits recalled for sterility failure
FDA (Devices) · 2026-07-22
Similar recalls
- SevereSCA Pharmaceuticals Recalls Fentanyl and Bupivacaine Injection Bags
FDA (Drugs) · 2017-11-08
- SevereSCA Pharmaceuticals Recalls Fentanyl and Bupivacaine Infusion Bags for Sterility Concerns
FDA (Drugs) · 2017-08-02
- SevereSCA Pharmaceuticals Recalls Fentanyl and Bupivacaine Infusion Bags Due to Sterility Concerns
FDA (Drugs) · 2017-08-02
- HighSCA Pharmaceuticals Fentanyl-Bupivacaine Injectable Recall Due to Manufacturing Deviations
FDA (Drugs) · 2023-08-02
- SevereSCA Pharmaceuticals Recalls Fentanyl and Bupivacaine Injection Due to Sterility Concerns
FDA (Drugs) · 2017-08-02
- SevereSCA Pharmaceuticals Recalls Fentanyl and Bupivacaine Syringes Due to Sterility Concerns
FDA (Drugs) · 2021-01-13