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

Class I - Dangerous

What Should You Do?

Check if you have this product:
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
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Company:: First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Reason for Recall:: Lack of Assurance of Sterility
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: terminated

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

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

Always verify recall information with the official FDA source:

FDA Recall Number: D-0201-2020

First Royal Care Co. LLC

Class I - Dangerous

Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

Aug 13, 2021 Prescription Drugs View Details →

First Royal Care Co. LLC

Class I - Dangerous

Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

Aug 13, 2021 Prescription Drugs View Details →

First Royal Care Co. LLC

Class I - Dangerous

Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

Aug 13, 2021 Prescription Drugs View Details →