Why it was recalled
GMP Deviations: potential glass contamination
Product description
PF-Fentanyl Citrate 2 mcg/mL* & Ropivacaine HCl 0.1% in 0.9% Sodium Chloride Injection-200 mL Total Dose: (400 mcg/200 mg)/200 mL, Rx Only Nephron 503B Outsourcing Facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-526-20
Lot numbers, UPCs & expiration codes
Lot: FR9002A Exp. 12/12/2019
Where it was sold
Nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0149-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 9, 2019
- FDA report date
- Oct 30, 2019
- Quantity
- 615 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center
Original FDA data
Every field from FDA enforcement report D-0149-2020, exactly as published.
Show all FDA fields
- City
- West Columbia
- State
- SC
- Status
- Terminated
- Country
- United States
- Event ID
- 84000
- Address
- 4500 12th Street Ext
- Code information
- Lot: FR9002A Exp. 12/12/2019
- Postal code
- 29172-3025
- Report date
- Oct 30, 2019
- Product type
- Drugs
- Recall number
- D-0149-2020
- Classification
- Class II
- Recalling firm
- Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center
- Product quantity
- 615 bags
- Termination date
- Dec 1, 2020
- Reason for recall
- GMP Deviations: potential glass contamination
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- PF-Fentanyl Citrate 2 mcg/mL* & Ropivacaine HCl 0.1% in 0.9% Sodium Chloride Injection-200 mL Total Dose: (400 mcg/200 mg)/200 mL, Rx Only Nephron 503B Outsourcing Facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-526-20
- Distribution pattern
- Nationwide.
- Recall initiation date
- Oct 9, 2019
- Initial firm notification
- Letter
- Center classification date
- Oct 18, 2019