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
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot # 1223047134, Use By: 09/21/2023
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- SCA Pharmaceuticals
- Reason for Recall:
- cGMP deviations: due to shipment of rejected units.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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
Product Codes/Lot Numbers:
Lot # 1223047134, Use By: 09/21/2023
Distribution:
Distributed in: KY, NJ
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0945-2023
Related Recalls
Class I - Dangerous
Lack of Assurance of Sterility
labetalol HCl 20 mg/4mL Injection, (Concentration=5 mg/mL), 4 mL fill Syringe, Rx Only, SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0700-28, Bar Code 70004070028
SCA Pharmaceuticals
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
Lack of Assurance of Sterility