FDA Drug Recalls

Recalls / Class II

Class IID-1454-2022

Product

DAYQUIL COLD FLU LQD 12 FL OZ SKU 900205 RIC NIGHT TIME CLD FLU RLF SOFT GELS 8 CT SKU 900523 ALKA SELTZER PLUS DAY NIGHT LGEL 20 CT SKU 902012 GS COLD FLU RELIEF NGHTTIME CHRY12FL OZ SKU 917523 RIC COLD FLU DAY TIME LIQUID CAP 16 CT SKU 903037 ASP SEVERE COLD COUGH CITRUS 20CT SKU 902906 ASP SEVERE COLD ORANGE ZEST 20CT SKU 902908 ALKA SELTZER PLUS SEVERE COLD ORIG 20CT SKU 903333 AS PLUS SINUS ALLERGY N COUGH PMAX 16CT SKU 903335 NYQUIL SEVERE VAPOCOOL LIQUID 8 FL OZ SKU 999542 AS PLUS MAX STRNGTH SINUS CONG N PN 20CT SKU 903334 GS DAYTIME COLD FLU RLF ORANGE 12FL OZ SKU 900576 NYQUIL SEVERE COLD FLU BERRY 8 FL OZ SKU 903759 NYQUIL ORGNL COLD AND FLU LQD 12FL OZ SKU 900207 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.

Affected lot / code info
SKUs: 900205; 900523; 902012; 917523; 903037; 902906; 902908; 903333; 903335; 999542; 903334; 900576; 903759; 900207

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-1454-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.