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Class II: temporary or reversible health riskTerminated

H & H Remedies Vapor Ointment packaged in a) 1/8 oz Recall

Vapor Ointment packaged in a) 1/8 oz

H & H Remedies, LLC · New Philadelphia, OH

Risk level
Class II
Reported by FDA
Nov 18, 2020
Recall ID
D-0073-2021
Check your lot numberHow we source this data

Summary

H & H Remedies recalled Vapor Ointment packaged in a) 1/8 oz starting Oct 21, 2020. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0073-2021 on Nov 18, 2020. Reason: CGMP Deviations. Status: Terminated.

Why it was recalled

CGMP Deviations

Product description

Vapor Ointment packaged in a) 1/8 oz; b) 2 oz.; c) 4 oz.; and d) 8 oz jars. Mfg & Sold by: H & H Remedies, LLC c/o David A. Cox, 1219 South Broadway, New Philadelphia, OH 44663

Lot numbers, UPCs & expiration codes

Lot #: H20-01V thru H20-10V

Where it was sold

Nationwide in the United States

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-0073-2021
Classification
Class II
Status
Terminated
Recall initiated
Oct 21, 2020
FDA report date
Nov 18, 2020
Quantity
252 jars
Recall type
Voluntary: Firm initiated
Recalling firm
H & H Remedies, LLC

Original FDA data

Every field from FDA enforcement report D-0073-2021, exactly as published.

Show all FDA fields
City
New Philadelphia
State
OH
Status
Terminated
Country
United States
Event ID
86712
Address
1219 S Broadway St
Code information
Lot #: H20-01V thru H20-10V
Postal code
44663-9565
Report date
Nov 18, 2020
Product type
Drugs
Recall number
D-0073-2021
Classification
Class II
Recalling firm
H & H Remedies, LLC
Product quantity
252 jars
Termination date
May 12, 2024
Reason for recall
CGMP Deviations
Voluntary / mandated
Voluntary: Firm initiated
Product description
Vapor Ointment packaged in a) 1/8 oz; b) 2 oz.; c) 4 oz.; and d) 8 oz jars. Mfg & Sold by: H & H Remedies, LLC c/o David A. Cox, 1219 South Broadway, New Philadelphia, OH 44663
Distribution pattern
Nationwide in the United States
Recall initiation date
Oct 21, 2020
Initial firm notification
Press Release
Center classification date
Nov 9, 2020

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0073-2021, published Nov 18, 2020. 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.

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