Ear Care Earache Drops Liquid
FDA Recall NDC 11822-3644
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Ear Care Earache Drops (NDC 11822-3644). A significant event, classified as Class II, was initiated on May 24, 2022 by Rite Aid Corporation. The reported reason for this action was: "Microbial contamination of non-sterile product."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Microbial contamination of non-sterile product.
May 24, 2022
Jun 15, 2022
16,374 bottles
Recall Profile & Regulatory Data
Event ID
90297
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Grato Holdings, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the USA
Termination Date
Jun 08, 2023
Product Description
Homeopathic EarAche Drops, 0.33 FL OZ (10 mL) bottles, Distributed by: RITE AID, 30 Hunter Lane, Camp Hill, PA 17011. NDC 11822-3644-3
Batch or Lot Expiration Information
Lot# : G11639, Exp. Date 09/24
Affected Packages Involved in this Recall
11822-3644-3Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
