FDA Recall D-1450-2022

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

QP DPHNHDRME ALRGY MIN TBLT 12 CT SKU 900449 QP ALLERGY DIPHENHYDRAMINE 25 MG 48 CT SKU 916003 QP ALLERGY MULTI SYMPTOM CAPLET 24CT SKU 916918 BENADRYL D CHILD ALLERGY SINUS GRAPE 4FO SKU 901738 GOOD SENSE CHILD ALLERGY CHERRY 4 FL OZ SKU 916917 BENADRYL ALLERGY CONGESTN ULTRA TAB 24CT SKU 999834 BENADRYL ALLERGY ULTRATAB 24CT SKU 902217 BENADRYL ALLERGY LIQUIDGELS 24 CT SKU 916715 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.

Lot / code: SKUs: 900449; 916003; 916918; 901738; 916917; 999834; 902217; 916715

Quantity: Unknown

Reason for recall

CGMP Deviations: product held outside appropriate storage temperature conditions.

Recall record

Recall number: D-1450-2022
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