FDA Recalls SCA Fentanyl-Bupivacaine Epidural Injection Cassettes Lacking Sterility Assurance
SCA Pharmaceuticals is recalling 613 cassettes of fentanyl-bupivacaine epidural injection nationwide 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: This is a Class II pharmaceutical recall involving a sterility assurance failure for an epidural injection medication. No illnesses, injuries, or hospitalizations have been reported, making this a theoretical risk recall. Per the rubric, recalls with theoretical hazards and no reported harm score at most 3 (High).
Plain-English summary
SCA Pharmaceuticals, LLC is recalling 613 cassettes of fentanyl 200 mcg/100 mL and bupivacaine HCl 0.125% in 0.9% sodium chloride 100 mL injection for epidural use. The 100 mL yellow CADD cassettes are being recalled due to lack of assurance of sterility.
The affected product has been distributed nationwide. The recall involves three lot numbers: 1223049754 (expiration 01/12/24), 1223049992 (expiration 01/23/24), and 1223050066 (expiration 01/25/24).
Patients and healthcare providers using or considering use of these products should contact SCA Pharmaceuticals or their healthcare provider. The manufacturer cannot assure sterility for the affected cassettes. Patients should not use these products and should consult their healthcare provider about alternative treatment options.
No illnesses or injuries have been reported in connection with this recall.
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 Yellow CADD Cassette, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0231-64, Bar Code 70004023164
- Manufacturer
- SCA Pharmaceuticals, LLC
- Category
- Drug
- Hazard
- Affected units
- 613
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 (6)
- Lot #: 1223049754
- Exp 01/12/24
- 1223049992
- Exp 01/23/24
- 1223050066
- Exp 01/25/24
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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