RecallHawk
Class II Recall

BANANA BOAT SPRT CLR SPRY SPF50 6 FL OZ SKU 2007524 SUNTONE SPORT SPRAY SPF 50 5.5 OZ SKU 2096102 HAWAIIAN TROPIC TAN

Family Dollar Stores, Llc.

Summary

The FDA issued a Class II for BANANA BOAT SPRT CLR SPRY SPF50 6 FL OZ SKU 2007524 SUNTONE SPORT SPRAY SPF 50 by Family Dollar Stores, Llc.. Reason: CGMP Deviations: product held outside appropriate storage temperature conditions..

Details

Source

Drug Recall

External ID

D-1365-2022

Action Date

2022-08-31

Status

Ongoing

Category

drug

Product Description

BANANA BOAT SPRT CLR SPRY SPF50 6 FL OZ SKU 2007524 SUNTONE SPORT SPRAY SPF 50 5.5 OZ SKU 2096102 HAWAIIAN TROPIC TANNING OIL SPRAY PUMP SPF 25 8 FL OZ SKU 2096111 BANANA BOAT SPORT ULTRAMIST SPRAY SPF 65 6 OZ SKU 2096117 COPPERTONE WATERBABIES LOTION SPF 50 8 FL OZ SKU 2097635 COPPERTONE SPORT SPRAY SPF 50 5.5 OZ SKU 2097636 BANANA BOAT SPRT LTION SPF 50 8 FL OZ SKU 2099592 HAWAIIAN TROPIC SHEER TOUCH LOTION SPF 30 8 FL OZ SKU 2006432 BB KIDS SUN SCREEN MIST SPRAY SPF 100 6 OZ SKU 2007523 SUNTONE KIDS SPRAY SPF 50 6 OZ SKU 2096096 NEUTROGENA BCH DFNSE SPR SPF 70 SKU 2097632 BANANA BOAT KDS SPRT SPRY SPF50 6FL OZ SKU 2097655 BANANA BOAT DRY OIL MST SPRY 15 SPF 6 OZ SKU 2097794 BANANA BOAT TAN DRY OIL MIST 4 SPF 6 OZ SKU 2097144 COPPERTONE GLOW SPRAY SPF 50 5OZ SKU 2096124 COPPERTONE SPORT LOTION SPF 50 8.75 FLOZ SKU 2096130 NEUTROGENA ULTRA SHEER LOTN SPF 55 3 FL OZ SKU 2097637 SUNTONE KIDS LOTION SPF 50 6 FL OZ SKU 2096101 BANANA BOAT SPORT ULTRA MIST 30 SPF 6 OZ SKU 2097141 COPPERTONE SPORT SPRAY SPF30 5.5OZ SKU 2097083 SUNTONE SPORT SPRAY SPF 70 5.5 OZ SKU 2008234 SUNTONE SPORT LOTION SPF 50 6 FL OZ SKU 2096099 COPPERTONE KIDS SPRAY SPF 50 5.5 OZ SKU 2097084 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.

Lot/Code Info: SKUs: 2007524, 2096102, 2096111, 2096117, 2097635, 2097636, 2099592, 2007523, 2096096, 2097632, 2097655, 2097794, 2097144, 2096124, 2096130, 2097637, 2096101, 2097141, 2097083, 2008234, 2096099, 2097084; 2006432

Quantity Affected: Unknown

Reason for Recall

CGMP Deviations: product held outside appropriate storage temperature conditions.

Distribution

Nationwide within the United States

Type: Voluntary: Firm initiated

Recall Initiated: 2022-06-23

Company

Context & Analysis

This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.

This was one of 131 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.

Family Dollar Stores, Llc. has 149 FDA actions in our database, including 149 recalls.

Frequently Asked Questions

What is a Class II recall?

A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Family Dollar Stores, Llc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does Family Dollar Stores, Llc. have FDA actions?

Family Dollar Stores, Llc. has 149 FDA actions in our database, including 149 recalls and 0 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "D-1365-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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