FDA Recalls Fentanyl and Bupivacaine Injection Due to Sterility Concerns
SCA Pharmaceuticals is recalling 324 syringes of fentanyl/bupivacaine epidural injection nationwide due to lack of sterility assurance. Patients should contact their healthcare provider if affected.
What this means for you
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: This is an FDA Class II recall for lack of sterility assurance in an injectable epidural medication. No illnesses or injuries are reported in the source text, but this constitutes a risk-of-harm product where contamination or infection could occur.
Plain-English summary
SCA Pharmaceuticals is recalling 324 syringes of fentanyl 100 mcg/50 mL combined with bupivacaine HCl 0.125% in sodium chloride 0.9% injection. The product is for epidural use only. The affected lot is Lot #1223049125, which expires December 4, 2023.
The recall is due to lack of assurance of sterility. The manufacturer cannot guarantee that the product meets required sterility standards.
The product was distributed nationwide. Patients who have received injections from this lot should contact their healthcare provider. Healthcare facilities should check their inventory for this product and consult with the FDA regarding remaining stock.
The recalled product
- Product
- fentaNYL 100 mcg/50 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 50 mL Injection (fentaNYL Concentration = 2 mcg/mL), EPIDURAL USE ONLY, 50 mL fill Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd, Windsor, CT 06095, NDC 70004-0231-22, Bar Code 70004023122
- Manufacturer
- SCA Pharmaceuticals, LLC
- Category
- Drug — Injectable / Epidural
- Hazard
- lack-of-sterility
- infection-risk
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 #: 1223049125
- Exp 12/04/23
Distribution
Distributed nationwide across the United States.
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