FDAClass IINovember 13, 2019

S-atropine 0.01% Ophthalmic Solution recall: Sterility Concern

S-ATROPINE 0.01% OPHTHALMIC SOLUTION, packaged in a) 10ml and b) 50 ml dropper bottle, Rx only, Red Mountain Compounding RX.

Why was S-atropine 0.01% Ophthalmic Solution 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) S06112019DH@22, Exp 9/11/19; S06202019DT@10, Exp 9/20/19; S07312019DH@07, Exp 10/31/19; b) S07302019DH@07, Exp 10/30/19

Product
S-ATROPINE 0.01% OPHTHALMIC SOLUTION, packaged in a) 10ml and b) 50 ml dropper bottle, Rx only, Red Mountain Compounding RX.
Recalling firm
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Quantity
6x10 ml, 1x50 ml dropper bottle
Distribution
Nationwide in the USA
Recall date
November 13, 2019
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls