FDAClass IINovember 13, 2019

S-DMSO 100% recall: Sterility Concern

S-DMSO 100% (PF) STERILE SOLUTION; packaged in a) 50 ml and b) 10 ml glass vials, Rx Only, Red Mountain Compounding Rx

Why was S-DMSO 100% 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 #:a) S04242019DT@15, Exp 10/24/19; S05012019DH@03, Exp 11/1/19; S05072019DT@10, Exp 11/7/19; S05072019DT@12, Exp 11/7/19; S06202019DT@03, Exp 12/20/19; S06202019DT@04, Exp 12/20/19; S07222019DH@05, Exp 07/22/2019 b) S06272019DT@06, Exp 12/27/19;

Product
S-DMSO 100% (PF) STERILE SOLUTION; packaged in a) 50 ml and b) 10 ml glass vials, Rx Only, Red Mountain Compounding Rx
Recalling firm
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Quantity
10x50m ml and 1x10 ml glass vials
Distribution
Nationwide in the USA
Recall date
November 13, 2019
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls