FDA Drug Recalls

Recalls / Class II

Class IID-1414-2022

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.

Affected lot / code info
SKUs: 901379; 999845; 913102; 914109; 914726; 914112; 902322

Why it was recalled

CGMP Deviations: product held outside appropriate storage temperature conditions.

Recalling firm

Firm
Family Dollar Stores, Llc.
Notification channel
Other
Type
Voluntary: Firm initiated
Address
500 Volvo Pkwy, Chesapeake, Virginia 23320-1604

Distribution

Quantity
Unknown
Distribution pattern
Nationwide within the United States

Timeline

Recall initiated
2022-06-23
FDA classified
2022-08-22
Posted by FDA
2022-08-31
Status
Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-1414-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class II recall: drug · FDA Drug Recalls