April 2022 FDA Recall Drug by Bestco Llc
D-0879-2022 - Subpotent drug

This Class III drug recall was voluntarily initiated by Bestco Llc on April 27, 2022 for the product Drug. The FDA reported the reason for recall as subpotent drug. The product was distributed in CA, ID, PA, OK and the recall is currently terminated.

Recall Number: D-0879-2022

Reason for Recall
Subpotent drug: Low OOS for menthol content at the three month room temperature.
Initiated
04-27-2022
Reported
05-25-2022
Quantity
2038 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
90124
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Bestco LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
CA, ID, PA, OK
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-05-2024
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

Lot# : 100010885, Exp 11/2024