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FDADecember 17, 2020drug

PHENYLephrine HCl 500 mcg/5mL in 0.9% Sodium Chloride (100 mcg/mL), Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004081011

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

The hazard

Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit

What to do

FDA enforcement status: Terminated

Brands named

sca pharmaceuticalssca

UPCs

70004081011

Recall history

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

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PHENYLephrine HCl 500 mcg/5mL in 0.9% Sodium Chloride (100 mcg/mL), Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004081011 — Recall Details · AllClear