PF-Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL), One 4 mL Unit-Dose Vial, packaged in 30 x 4 mL Sterile Unit-dose Vials per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 69374-946-34
Reported: August 24, 2022 Initiated: August 10, 2022 #D-1347-2022
Product Description
PF-Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL), One 4 mL Unit-Dose Vial, packaged in 30 x 4 mL Sterile Unit-dose Vials per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 69374-946-34
Reason for Recall
CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
Details
- Recalling Firm
- Nephron Sterile Compounding Center LLC
- Units Affected
- 33,870 vials
- Distribution
- Nationwide in the USA
- Location
- West Columbia, SC
Frequently Asked Questions
What product was recalled? ▼
PF-Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL), One 4 mL Unit-Dose Vial, packaged in 30 x 4 mL Sterile Unit-dose Vials per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 69374-946-34. Recalled by Nephron Sterile Compounding Center LLC. Units affected: 33,870 vials.
Why was this product recalled? ▼
CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 24, 2022. Severity: Moderate. Recall number: D-1347-2022.
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