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FDANovember 10, 2022drug

PF-Labetalol HCl Injection, USP 20 mg/4 mL (5 mg/mL) vial, Rx Only, Nephron 503B Outsourcing Facility 4500 12th Street Extension West Columbia, SC 29172, NDC 69374-946-34, UPC 3 69374 94634 6.

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

The hazard

CGMP Deviations: Potential for cross contamination due to product carry over.

What to do

FDA enforcement status: Terminated

Brands named

nephron sterile compounding centernephronnephron sterile

UPCs

369374946346

Recall history

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

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PF-Labetalol HCl Injection, USP 20 mg/4 mL (5 mg/mL) vial, Rx Only, Nephron 503B Outsourcing Facility 4500 12th Street Extension West Columbia, SC 29172, NDC 69374-946-34, UPC 3 69374 94634 6. — Recall Details · AllClear