SCA Pharmaceuticals Fentanyl-Bupivacaine Injectable Recall Due to Manufacturing Deviations
SCA Pharmaceuticals is recalling 183 bags of a fentanyl-bupivacaine injectable due to current Good Manufacturing Practice (cGMP) deviations. The product was distributed to Kentucky and New Jersey.
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 classification applies. No illnesses or injuries have been reported. The hazard is a manufacturing quality control issue on an injectable pharmaceutical product, which presents risk of harm but has not yet resulted in documented injury.
Plain-English summary
SCA Pharmaceuticals is recalling 183 bags of FentaNYL 500 mcg/250 mL combined with Bupivacaine HCl 0.1% in 0.9% Sodium Chloride 250 mL injection. The recall is due to current Good Manufacturing Practice (cGMP) deviations resulting from the shipment of rejected units.
The affected product is lot number 1223047134 with a use-by date of 09/21/2023. Distribution was limited to Kentucky and New Jersey.
Patients and healthcare providers should not use the recalled product. Patients currently using this medication should consult their healthcare provider about alternative treatment options.
For more information, contact SCA Pharmaceuticals at 755 Rainbow Rd, Windsor, CT 06095 or visit the FDA at https://www.fda.gov/drugs/drug-safety-and-availability/drug-recalls.
The recalled product
- Product
- FentaNYL 500 mcg/250 mL - Bupivacaine HCl 0.1% in 0.9% Sodium Chloride 250mL Bag, Injection for Epidural Use (fentaNYL Concentration - 2 mcg/mL), Rx Only, Single Dose Container, SCA Pharmaceuticals, 755 Rainbow Rd, Windsor, CT 06095, NDC# 70004-0253-40
- Manufacturer
- SCA Pharmaceuticals
- Category
- Drug — Injectable Pharmaceutical
- Hazard
- Affected units
- 183
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 # 1223047134
- Use By: 09/21/2023
Distribution
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