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Class III: unlikely to cause harmTerminated

Bestco Open Nature Cough Drops Menthol-Cough Recall

Open Nature Cough Drops Menthol-Cough Suppressant/Oral Anesthetic Peppermint Naturally…

Bestco LLC · Mooresville, NC

Risk level
Class III
Reported by FDA
May 25, 2022
Recall ID
D-0879-2022
Check your lot numberHow we source this data

Summary

Bestco recalled Open Nature Cough Drops Menthol-Cough starting Apr 27, 2022. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0879-2022 on May 25, 2022. Reason: Subpotent drug: Low OOS for menthol content at the three month room temperature. Status: Terminated.

Why it was recalled

Subpotent drug: Low OOS for menthol content at the three month room temperature.

Product description

Open Nature Cough Drops Menthol-Cough Suppressant/Oral Anesthetic Peppermint Naturally Flavored, packaged in Bags of 30 lozenges, Distributed By Lucerne Foods, Inc. P.O. Box 99, Pleasanton, CA 96566-0009, UPC 0 79893 41266 5

Lot numbers, UPCs & expiration codes

Lot #: 100010885, Exp 11/2024

Where it was sold

CA, ID, PA, OK

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-0879-2022
Classification
Class III
Status
Terminated
Recall initiated
Apr 27, 2022
FDA report date
May 25, 2022
Quantity
2038 bags
Recall type
Voluntary: Firm initiated
Recalling firm
Bestco LLC

Original FDA data

Every field from FDA enforcement report D-0879-2022, exactly as published.

Show all FDA fields
City
Mooresville
State
NC
Status
Terminated
Country
United States
Event ID
90124
Address
288 Mazeppa Rd
Code information
Lot #: 100010885, Exp 11/2024
Postal code
28115-7928
Report date
May 25, 2022
Product type
Drugs
Recall number
D-0879-2022
Classification
Class III
Recalling firm
Bestco LLC
Product quantity
2038 bags
Termination date
Jan 5, 2024
Reason for recall
Subpotent drug: Low OOS for menthol content at the three month room temperature.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Open Nature Cough Drops Menthol-Cough Suppressant/Oral Anesthetic Peppermint Naturally Flavored, packaged in Bags of 30 lozenges, Distributed By Lucerne Foods, Inc. P.O. Box 99, Pleasanton, CA 96566-0009, UPC 0 79893 41266 5
Distribution pattern
CA, ID, PA, OK
Recall initiation date
Apr 27, 2022
Initial firm notification
E-Mail
Center classification date
May 18, 2022

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0879-2022, published May 25, 2022. View the source record (openFDA) · FDA enforcement reports

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

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