FDA Recalls Fentanyl-Bupivacaine Injection Due to Sterility Assurance Concerns
SCA Pharmaceuticals is recalling 130 cassettes of a fentanyl-bupivacaine epidural injection distributed nationwide due to 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 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 drug recall with no reported illnesses or injuries. The hazard (lack of sterility assurance) represents a theoretical risk-of-harm to patients without confirmed contamination.
Plain-English summary
SCA Pharmaceuticals, LLC is recalling fentaNYL 500 mcg/100 mL combined with Bupivacaine HCl 0.075% in 0.9% Sodium Chloride 100 mL Injection (CADD Cassette, NDC 70004-0251-64). The recall affects 130 cassettes distributed nationwide due to lack of assurance of sterility.
The two affected lots are: Lot #1223048722 (Exp 11/29/23) and Lot #1223049096 (Exp 12/15/23). This product is intended for epidural use only.
Patients currently using this product should contact their healthcare provider. Healthcare providers should quarantine affected cassettes and refer to the FDA recall notice for further instructions.
The recalled product
- Product
- fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.075% 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 70004-0251-64, Bar Code…
- Manufacturer
- SCA Pharmaceuticals, LLC
- Category
- Drug — Injectable / Epidural
- Affected units
- 130
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 #: 1223048722
- Exp 11/29/23
- 1223049096
- Exp 12/15/23
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.
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