May 2021 FDA Recall Drug by Accupac, Inc.
D-0598-2021 - Labeling

This Class II drug recall was voluntarily initiated by Accupac, Inc. on May 13, 2021 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed in Naitonwide in the US and Puerto Rico. and the recall is currently terminated.

Recall Number: D-0598-2021

Reason for Recall
Labeling: Not Elsewhere Classified; the primary label (tube) may be incorrectly labeled as Fluoride-Free instead of With Fluoride
Initiated
05-13-2021
Reported
06-02-2021
Quantity
2,261 cases/24 tubes per case = 54,264 tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87944
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Accupac, Inc.
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.
Naitonwide in the US and Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-11-2021
Product Description About Product Description
Full technical description of the product.
Native Fluoride Toothpaste for Sensitive Teeth, with Fluoride, 5% potassium nitrate, 0.243% sodium fluoride (0.14% w/v fluoride ion), Net Wt. 4.1 oz.,116 g, , Distr by Native, San Francisco, CA 94111 NDC: 69423-903-41, UPC 0 37000 28803 9

Batch or Lot Expiration Information

Lot# LOT 0317M107 with expiry Oct 12 2022 LOT1075M107 with expiry Feb 16 2023