Fentanyl and Bupivacaine Epidural Injection Recalled for Sterility Assurance Issue
SCA Pharmaceuticals recalls 412 cassettes of fentanyl-bupivacaine epidural injection (lots 1223049261 and 1223049724) due to lack of assurance of sterility.
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: FDA Class II recall for lack of sterility assurance in a high-risk sterile injectable product for epidural use. As a risk-of-harm product with no indication of reported injuries, this meets the High severity criterion.
Plain-English summary
SCA Pharmaceuticals is recalling 412 cassettes of fentanyl 500 mcg/100 mL with bupivacaine HCl 0.04% in 0.9% sodium chloride epidural injection. The affected lots are 1223049261 (expiration 12/25/23) and 1223049724 (expiration 01/11/24).
The recall was initiated due to lack of assurance of sterility for these lots. Epidural injections require sterile product, and the affected cassettes may not meet required sterility standards.
The product was distributed nationwide in the United States. Healthcare facilities and providers who have received cassettes from the affected lots should verify their stock immediately.
Facilities should discontinue use of cassettes from the affected lots and contact their pharmacy or SCA Pharmaceuticals for replacement product or further information.
The recalled product
- Product
- fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.04% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL Concentration = 5 mcg/mL), EPIDURAL USE ONLY, 100 mL Yellow CADD Cassette, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0289-64, Bar Code 70004028964
- Manufacturer
- SCA Pharmaceuticals, LLC
- Category
- Drug — Injectable / Epidural
- Hazard
- sterility-failure
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 (4)
- Lot #: 1223049261
- Exp 12/25/23
- 1223049724
- Exp 01/11/24
Distribution
Distributed nationwide across the United States.
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