FDA Drug Recalls

Recalls / Class II

Class IID-1452-2022

Product

READY IN CASE CTRZNE ALRGY ALL DY TBLT 5 CT SKU 900448 ZYRTEC CHILDRENS GRAPE 4 FL OZ SKU 999368 GOOD SENSE ALLERGY CETIRIZINE 10 MG TABLET 14 CT SKU 916897 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.

Affected lot / code info
SKUs: 900448; 999368; 916897

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-1452-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.