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Ketamine 50 mg/5 mL in 0.9% Sodium Chloride Injection for IV or IM Use (concentration = 10 mg/mL)...

FDA Recall #D-1843-2019 — Class II — August 16, 2019

Recall #D-1843-2019 Date: August 16, 2019 Classification: Class II Status: Terminated

Product Description

Ketamine 50 mg/5 mL in 0.9% Sodium Chloride Injection for IV or IM Use (concentration = 10 mg/mL), 6 mL Syringe, Rx Only, SCA Pharmaceuticals, Windsor, CT 06095, NDC 70004-0430-09.

Reason for Recall

Lack of Assurance of Sterility.

Recalling Firm

SCA Pharmaceuticals, LLC — Windsor, CT

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

922 syringes

Distribution

Nationwide in the U.S.

Code Information

Lot #: 1219010961, Exp. 10/24/2019

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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