FDAClass IIAugust 28, 2019

Ketamine 50 mg/5 mL in 0.9% Sodium Chloride Injection recall: Sterility Concern

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…

Why was Ketamine 50 mg/5 mL in 0.9% Sodium Chloride Injection recalled?

Lack of Assurance of Sterility.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
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…
Recalling firm
SCA Pharmaceuticals, LLC
Quantity
922 syringes
Distribution
Nationwide in the U.S.
Recall date
August 28, 2019
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls