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.
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 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.
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