Recall Z-1538-2022— Family Dollar Stores, Llc.

Name: FDA recall Z-1538-2022
Creator: U.S. Food and Drug Administration
Published: 2022-06-23

Class II · Ongoing

Class II FDA medical device recall by Family Dollar Stores, Llc., initiated 2022-06-23. It names one FDA 510(k) clearance: K945200. Product: FIXODENT ORG CREAM 2.4OZ, SKU 906018 FIXODENT ORG CREAM TRAVEL .75OZ, SKU 901239. Reason: Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022..

Recalling firm: Family Dollar Stores, Llc.
Classification: Class II
Status: Ongoing
Initiated: 2022-06-23
Firm location: Chesapeake, VA, United States

510(k) clearances named in this recall

1 on FDA's record

K945200 — FIXODENT, FIXODENT FRESH, FASTEETH AND EXTRA HOLD FASTEETH DENTURE ADHESIVCESProcter & Gamble Co.·cleared 1994-11-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

FIXODENT ORG CREAM 2.4OZ, SKU 906018 FIXODENT ORG CREAM TRAVEL .75OZ, SKU 901239

Reason for recall

Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.

Data sourced from openFDA. This site is unofficial and independent of the FDA.