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FDAAugust 10, 2022drug

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.

What to do

FDA enforcement status: Terminated

Brands named

nephron sterile compounding centernephronnephron sterile

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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