Recall Enforment Report D-0852-2021

Multi event Drug Recall Enforcement Report Class III voluntary initiated by New Vision Pharmaceuticals LLC, originally initiated on 09-02-2021 for the product Daytime Severe Cold & Flu Relief 8 Pre-Measured Vials 0.51 FL OZ (15 mL) Each 4.06 FL OZ (120 mL) Total/Nighttime Severe Cold & Flu Relief 8 Pre-Measured Vials 1.01 FL OZ (30 mL) Each 8.12 FL OZ (240 mL) Total Single-Use Vials Mixed Berry Flavor NDC 69842-495-16 UPC 0 50428 64057 9 Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 The product was recalled due to subpotent drug. The product was distributed in Al, Ca, Fl, In, Mi, Mo, Nj, Ny, Pa, Ri, Sc, Tn, Tx, Va and the recall is currently ongoing.

Recall Enforcement Reports

Recall Number Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0852-202109-02-202110-06-2021Class III14,976 FG cartonsDaytime Severe Cold & Flu Relief 8 Pre-Measured Vials 0.51 FL OZ (15 mL) Each 4.06 FL OZ (120 mL) Total/Nighttime Severe Cold & Flu Relief 8 Pre-Measured Vials 1.01 FL OZ (30 mL) Each 8.12 FL OZ (240 mL) Total Single-Use Vials Mixed Berry Flavor NDC 69842-495-16 UPC 0 50428 64057 9 Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895Subpotent DrugOngoing
D-0853-202109-02-202110-06-2021Class III18,864 FG cartonsCVS Health Daytime Severe Cold & Flu Relief Single-Use Vials Mixed Berry Flavor 8 Pre-Measured Vials 0.51 FL OZ (15 mL) Each 4.06 FL OZ (120 mL) Total NDC 69842-499-08 UPC 0 50428 64130 9 Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895Subpotent DrugOngoing

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
69842-495Cvs Daytime And Nighttime Severe Cold And Flu Relief Bundle Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Doxylamine Succinate, Phenylephrine HclKitOralCvs PharmacyHuman Otc Drug