Grato Holdings, Inc.: Drug Recall

Recall #D-0990-2022 · 05/24/2022

Class II: Risk

Recall Details

Recall Number: D-0990-2022
Classification: Class II
Product Type: Drug
Recalling Firm: Grato Holdings, Inc.
Status: Terminated
Date Initiated: 05/24/2022
Location: Woodbine, IA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 50,640 bottles

Reason for Recall

Microbial contamination of non-sterile product.

Product Description

Homeopathic EarAche Ear Drops, 0.33 FL OZ (10 mL) bottles, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895. NDC 59779-568-15

Distribution Pattern

Nationwide within the USA

Other Recalls by Grato Holdings, Inc.

Class II: Risk 05/03/2024

Potential microbial contamination (yeast and/or mold).
Class II: Risk 05/03/2024

Potential microbial contamination (yeast and/or mold).
Class III: Low Risk 10/30/2023

Incorrect Product Formulation: product contains Active Ingredient Glandula Suprarenalis Suis 8X instead of Glandula Suprarenalis Bovine 8X (as stated on the product label).
Class II: Risk 05/24/2022

Microbial contamination of non-sterile product.
Class II: Risk 05/24/2022

Microbial contamination of non-sterile product.

View all recalls by Grato Holdings, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.