FDA Recall D-1424-2022

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

FW ASPIRIN CHEWABLE TABLET 36CT SKU 913990 GS ENTERIC ASPIRIN TABLET 120 CT SKU 913724 BAYER BACK BODY EX STRGTH CAPLETS 24CT SKU 900438 BAYER LOW DOSE 81 MG TABLET 120 CT SKU 916070 BAYER ASPIRIN 325MG TABLET 24CT SKU 913996 BAYER LOW DOSE TABLET 32CT SKU 915641 BAYER 81MG CHEWABLE TABLET 36 CT SKU 916078 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.

Lot / code: SKUs: 913990; 913724; 900438; 916070; 913996; 915641; 916078

Quantity: Unknown

Reason for recall

CGMP Deviations: product held outside appropriate storage temperature conditions.

Recall record

Recall number: D-1424-2022
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