Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1544-2022Class II

Polident Denture Cleansers 84 CT, Sku 901634 Polident Denture Clns Tab 28Ct, Sku 906131

Family Dollar Stores / initiated 2022-06-23 / Open, Classified

Family Dollar Stores, Llc. began a recall of POLIDENT DENTURE CLEANSERS 84 CT, SKU 901634 POLIDENT DENTURE CLNS TAB 28CT, SKU 906131 on . FDA classified it as Class II and gives the reason as "Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022". As of , the recall status on record is Open, Classified.

Recall record

Recall number
Z-1544-2022
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
Family Dollar Stores
Product
Polident Denture Cleansers 84 CT, Sku 901634 Polident Denture Clns Tab 28Ct, Sku 906131
Product code
EFT Cleanser, Denture, Over The Counter
Reason for recall
Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.
FDA root cause
Storage
Action
On June 23, 2022, the firm notified affected Family Dollar retail stores via an urgent Pull and Hold notice, effective June 24, 2022. Retail stores were informed that due to a shipping issue, the affected products could not be sold. Stores were instructed to remove affected products from the sales floor and quarantine them. https://www.familydollar.com/file/general/Voluntary_Recall_of_Certain_Over_the_Counter_Products_080522.pdf
Quantity in commerce
34
Distribution
Product distributed to Family Dollar retail stores in US nationwide.
Product codes and lots
All product sold between May 1, 2022 - June 10, 2022.

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1544-2022
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1526-2022Class IIOngoingVoluntary: Firm initiated
Z-1527-2022Class IIOngoingVoluntary: Firm initiated
Z-1528-2022Class IIOngoingVoluntary: Firm initiated
Z-1529-2022Class IIOngoingVoluntary: Firm initiated
Z-1530-2022Class IIOngoingVoluntary: Firm initiated
Z-1531-2022Class IIOngoingVoluntary: Firm initiated
Z-1532-2022Class IIOngoingVoluntary: Firm initiated
Z-1533-2022Class IIOngoingVoluntary: Firm initiated
Z-1534-2022Class IIOngoingVoluntary: Firm initiated
Z-1535-2022Class IIOngoingVoluntary: Firm initiated
Z-1536-2022Class IIOngoingVoluntary: Firm initiated
Z-1537-2022Class IIOngoingVoluntary: Firm initiated
Z-1538-2022Class IIOngoingVoluntary: Firm initiated
Z-1539-2022Class IIOngoingVoluntary: Firm initiated
Z-1540-2022Class IIOngoingVoluntary: Firm initiated
Z-1541-2022Class IIOngoingVoluntary: Firm initiated
Z-1542-2022Class IIOngoingVoluntary: Firm initiated
Z-1543-2022Class IIOngoingVoluntary: Firm initiated
Z-1544-2022Class IIOngoingVoluntary: Firm initiated
Z-1545-2022Class IIOngoingVoluntary: Firm initiated
Z-1546-2022Class IIOngoingVoluntary: Firm initiated
Z-1547-2022Class IIOngoingVoluntary: Firm initiated