RecallHawk
Class II Recall

DAYQUIL COLD FLU LQD 12 FL OZ SKU 900205 RIC NIGHT TIME CLD FLU RLF SOFT GELS 8 CT SKU 900523 ALKA SELTZER PLUS DAY

Family Dollar Stores, Llc.

Summary

The FDA issued a Class II for DAYQUIL COLD FLU LQD 12 FL OZ SKU 900205 RIC NIGHT TIME CLD FLU RLF SOFT GELS by Family Dollar Stores, Llc.. Reason: CGMP Deviations: product held outside appropriate storage temperature conditions..

Details

Source

Drug Recall

External ID

D-1454-2022

Action Date

2022-08-31

Status

Ongoing

Category

drug

Product Description

DAYQUIL COLD FLU LQD 12 FL OZ SKU 900205 RIC NIGHT TIME CLD FLU RLF SOFT GELS 8 CT SKU 900523 ALKA SELTZER PLUS DAY NIGHT LGEL 20 CT SKU 902012 GS COLD FLU RELIEF NGHTTIME CHRY12FL OZ SKU 917523 RIC COLD FLU DAY TIME LIQUID CAP 16 CT SKU 903037 ASP SEVERE COLD COUGH CITRUS 20CT SKU 902906 ASP SEVERE COLD ORANGE ZEST 20CT SKU 902908 ALKA SELTZER PLUS SEVERE COLD ORIG 20CT SKU 903333 AS PLUS SINUS ALLERGY N COUGH PMAX 16CT SKU 903335 NYQUIL SEVERE VAPOCOOL LIQUID 8 FL OZ SKU 999542 AS PLUS MAX STRNGTH SINUS CONG N PN 20CT SKU 903334 GS DAYTIME COLD FLU RLF ORANGE 12FL OZ SKU 900576 NYQUIL SEVERE COLD FLU BERRY 8 FL OZ SKU 903759 NYQUIL ORGNL COLD AND FLU LQD 12FL OZ SKU 900207 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.

Lot/Code Info: SKUs: 900205; 900523; 902012; 917523; 903037; 902906; 902908; 903333; 903335; 999542; 903334; 900576; 903759; 900207

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-1454-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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