FDA Drug Recalls

Recalls / Class II

Class IID-1392-2022

Product

READY IN CASE PAIN RELIEVER PM CAPLET 100 CT SKU 902381 GOOD SENSE PAIN RELIEVER APAP 500MG CAPLET 250CT SKU 902332 READY IN CASE PM PAIN RELIEVER CAPLET 50 CT SKU 913982 GOOD SENSE PAIN RELIEVER APAP ES 500 CT SKU 999029 GOOD SENSE PAIN RELIEVER CAPLET 100 CT SKU 913890 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.

Affected lot / code info
SKUs: 902381; 902332; 913982; 999029; 913890

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-1392-2022. 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