FDA Recall D-1414-2022

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

GUARDIAN ANTACID EX STRGTH TBLT FRT 96CT SKU 901379 GUARDIAN CHWABLE SMTHIES BRRY FSION 60CT SKU 999845 GS EFFERVESCENT ANTACID TABLET 36 CT SKU 913102 GUARDIAN ANTCD TBLT XTRA STGTH BRY 96 CT SKU 914109 GUARDIAN ANTCID TBLT REG STTH FRT 150 CT SKU 914726 GC ANTACID SUPREME CHERRY 12 FL OZ SKU 914112 GUARDIAN ANTD ULTR STRGTH 1000 FRT 72 CT SKU 902322 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.

Lot / code: SKUs: 901379; 999845; 913102; 914109; 914726; 914112; 902322

Quantity: Unknown

Reason for recall

CGMP Deviations: product held outside appropriate storage temperature conditions.

Recall record

Recall number: D-1414-2022
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