October 2023 FDA Recall Drug by Dollar Tree Distribution, Inc.
D-0045-2024 - CGMP Deviations

This Class II drug recall was voluntarily initiated by Dollar Tree Distribution, Inc. on October 5, 2023 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently ongoing.

Recall Number: D-0045-2024

Reason for Recall
CGMP Deviations: OTC products were stored outside of labeled temperature requirements.
Initiated
10-05-2023
Reported
10-25-2023
Quantity
4,261,383 units of various products

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
93187
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Dollar Tree Distribution, 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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Product Description About Product Description
Full technical description of the product.
Certain Over-The-Counter (OTC) drug products sold by Family Dollar retail stores.

Batch or Lot Expiration Information

Lot# Certain drug products sold by Family Dollar retail stores located in AL, AR, AZ, CA, CO, FL, GA, ID, KS, LA, MS, MT, ND, NE, NM, NV, OK, OR, SD, TX, UT, WA, and WY.