FDA Drug Recalls

Recalls / Class II

Class IID-1448-2022

Product

GUARDIAN BISMUTH CHWBLE CHRY TABS 30 CTSKU 902321 RIC BISMUTH MAXIMUM STRENGTH 8 FL OZ SKU 914325 PEPTO BISMOL ORIGINAL 8 FL OZ SKU 914324 RIC BISMUTH REG STRENGTH CHERRY 8 FL OZ SKU 914781 PEPTO BISMOL CHERRY 8 FL OZ SKU 916063 PEPTO B LIQUID ORIGINAL TRAVEL 3.4 FL OZ SKU 999812 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.

Affected lot / code info
SKUs: 902321; 914325; 914324; 914781; 916063; 999812

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-1448-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.