Ropivacaine HCl 123 mg (2.46 mg/mL), Clonidine HCl 0.04 mg (0.0008 mg/mL), Ketorolac Tromethamine 15 mg (0.3 mg/mL) Injection, 50 mL syringe, packaged in 5 x 50 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-515-50
Reported: July 27, 2022 Initiated: June 30, 2022 #D-1278-2022
Product Description
Ropivacaine HCl 123 mg (2.46 mg/mL), Clonidine HCl 0.04 mg (0.0008 mg/mL), Ketorolac Tromethamine 15 mg (0.3 mg/mL) Injection, 50 mL syringe, packaged in 5 x 50 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-515-50
Reason for Recall
Lack of Assurance of Sterility
Details
- Recalling Firm
- Nephron Sterile Compounding Center LLC
- Units Affected
- 2210 syringes
- Distribution
- Nationwide in the USA
- Location
- West Columbia, SC
Frequently Asked Questions
What product was recalled? ▼
Ropivacaine HCl 123 mg (2.46 mg/mL), Clonidine HCl 0.04 mg (0.0008 mg/mL), Ketorolac Tromethamine 15 mg (0.3 mg/mL) Injection, 50 mL syringe, packaged in 5 x 50 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-515-50. Recalled by Nephron Sterile Compounding Center LLC. Units affected: 2210 syringes.
Why was this product recalled? ▼
Lack of Assurance of Sterility
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 27, 2022. Severity: Moderate. Recall number: D-1278-2022.
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