Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

SKYN ORIGINAL NON LATEX CONDOM 12CT, SKU 903409 LS SKYN NON LATEX LUBRICATED CONDOM 3CT, SKU 900794 SKYN ELITE NON LATEX CONDOM 12CT, SKU 903415

FDA Recall Z-1530-2022 · Posted 2022-08-17

Recalling FirmFamily Dollar Stores, Llc.
Recall StatusOpen, Classified
Product CodeMOL
Date Initiated2022-06-23
Product Quantity2877 total

Reason for Recall

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

Firm 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

Root Cause

Storage

Distribution Pattern

Product distributed to Family Dollar retail stores in US nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K160399Skyn Original Polyisoprene Lubricated Male CondomAnsell Healthcare Products, LLC · 2016-07-25

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑