FDA Drug Recalls

Recalls / Class II

Class IID-1456-2022

Product

REFENESEN MUCUS RELIEF TABLET 30 CT SKU 917531 MUCINEX DM MAX STRENGTH 7CT SKU 900854 RIC MUCUS RLF DM MAX STNGTH CHRY 6FL OZ SKU 999559 VICKS JARABE COUGH CONGESTION 8FLOZ SKU 998933 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.

Affected lot / code info
SKUs: 917531; 900854; 999559; 998933

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-1456-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.