FindMyRecallSubscribe
Class II: temporary or reversible health riskTerminated

Grato Holdings Homeopathic EarAche Ear Drops Recall

Homeopathic EarAche Ear Drops, 0

Grato Holdings, Inc. · Woodbine, IA

Risk level
Class II
Reported by FDA
Jun 15, 2022
Recall ID
D-0990-2022
Check your lot numberHow we source this data

Summary

Grato Holdings recalled Homeopathic EarAche Ear Drops starting May 24, 2022. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0990-2022 on Jun 15, 2022. Reason: Microbial contamination of non-sterile product. Status: Terminated.

Why it was recalled

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

Lot numbers, UPCs & expiration codes

Lot #: G11639, Exp. Date 09/24

Where it was sold

Nationwide within the USA

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0990-2022
Classification
Class II
Status
Terminated
Recall initiated
May 24, 2022
FDA report date
Jun 15, 2022
Quantity
50,640 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Grato Holdings, Inc.

Original FDA data

Every field from FDA enforcement report D-0990-2022, exactly as published.

Show all FDA fields
City
Woodbine
State
IA
Status
Terminated
Country
United States
Event ID
90297
Address
201 Apple Blvd
Code information
Lot #: G11639, Exp. Date 09/24
Postal code
51579-1503
Report date
Jun 15, 2022
Product type
Drugs
Recall number
D-0990-2022
Classification
Class II
Recalling firm
Grato Holdings, Inc.
Product quantity
50,640 bottles
Termination date
Jun 8, 2023
Reason for recall
Microbial contamination of non-sterile product.
Voluntary / mandated
Voluntary: Firm initiated
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
Recall initiation date
May 24, 2022
Initial firm notification
Letter
Center classification date
Jun 8, 2022

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0990-2022, published Jun 15, 2022. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

How we source and update recall data · Report incorrect information

Other recent drug recalls