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FDADecember 17, 2020drug

Ketamine 100 mg/10mL in 0.9% Sodium Chloride Injection (10 mg/mL), CII, Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004043012

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

70004043012

Recall history

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

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