Certain Over-The-Counter (OTC) drug products sold by Family Dollar retail stores.
FDA Recall #D-0045-2024 — Class II — October 5, 2023
Product Description
Certain Over-The-Counter (OTC) drug products sold by Family Dollar retail stores.
Reason for Recall
CGMP Deviations: OTC products were stored outside of labeled temperature requirements.
Recalling Firm
Dollar Tree Distribution, Inc. — Chesapeake, VA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
4,261,383 units of various products
Distribution
Nationwide in the USA
Code Information
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.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated