Fentanyl 2 mcg/mL and ropivacaine 0.2% in 0.9% Sodium Chloride 150 mL, 150 mL bag, This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO. --- NDC: 88883-4272-01
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot, exp: 170621-008, 09/19/2017; 170703-002, 10/01/2017; 170711-031, 10/09/2017
- 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:
- SSM Health Care St. Louis DBA SSM St. Clare Health Center
- Reason for Recall:
- Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Fentanyl 2 mcg/mL and ropivacaine 0.2% in 0.9% Sodium Chloride 150 mL, 150 mL bag, This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO. --- NDC: 88883-4272-01
Product Codes/Lot Numbers:
Lot, exp: 170621-008, 09/19/2017; 170703-002, 10/01/2017; 170711-031, 10/09/2017
Distribution:
Distributed in: MO
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0138-2018
Related Recalls
Lack of Assurance of Sterility: Firm did not perform process validation.
Lack of Assurance of Sterility: Firm did not perform process validation.
HYDROmorphone HCl 10 mg in 0.9% Sodium Chloridge, 50 mL syringe (0.2 mg/mL), Rx Only, SSM Health Care Corporation Outsourcing Facility, 1015 Bowles Ave, Fenton, MO 63026-2394. NDC: 60652-0600-2
SSM Health Care St. Louis
CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.