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Recall Observatory FDA recall evidence

Drug product

CVS 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 02895

D-0853-2021

September 02, 2021

Class III

Product summary

Firm
New Vision Pharmaceuticals LLC
Event
Event 88608
Status
Terminated
Classification
Class III
Quantity
18,864 FG cartons
Official record key
drug-enforcement:D-0853-2021

Official wording

Reason: Subpotent Drug

Code information: Lots: 2021-10154 Exp. 06/29/2023; 2021-10164 Exp. 06/11/2023

Distribution pattern: AL, CA, FL, IN, MI, MO, NJ, NY, PA, RI, SC, TN, TX, VA

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Subpotent