FDA Recall D-1454-2022

Family Dollar Stores, Llc. · Chesapeake, VA

Class II Ongoing 1421 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

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

Quantity: Unknown

Reason for recall

CGMP Deviations: product held outside appropriate storage temperature conditions.

Recall record

Recall number: D-1454-2022
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Other
Distribution: Nationwide within the United States
Recall initiated: 2022-06-23
Classified by FDA Center: 2022-08-22
FDA published: 2022-08-31
Recalling firm: Family Dollar Stores, Llc.
Firm location: Chesapeake, VA

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

‹ All recalls