FDAClass IINovember 13, 2019

S-procaine HCL 2% Buffered recall: Sterility Concern

S-PROCAINE HCL 2% BUFFERED, Rx Only, a) PFV-single dose 10ml b)MDV 30ml glass vial, Red Mountain Compounding Rx

Why was S-procaine HCL 2% Buffered 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) S04162019DH@04, Exp 8/16/19;S04182019DT@11, Exp 8/18/19; S04302019DT@08, Exp 8/30/19; S05292019DT@11, Exp 9/29/19; S06092019DH@08, Exp 10/9/19, S06252019DH@15, Exp 10/25/19; S07022019DH@10, Exp 11/2/19, S07292019DH@11, Exp 11/29/19; b) S06032019DT@02, Exp 10/3/19; S07232019DH@03, Exp 11/23/19

Product
S-PROCAINE HCL 2% BUFFERED, Rx Only, a) PFV-single dose 10ml b)MDV 30ml glass vial, Red Mountain Compounding Rx
Recalling firm
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Quantity
N/A
Distribution
Nationwide in the USA
Recall date
November 13, 2019
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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