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Recall Observatory FDA recall evidence

Drug 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

D-0852-2021

September 02, 2021

Class III

Product summary

Firm
New Vision Pharmaceuticals LLC
Event
Event 88608
Status
Terminated
Classification
Class III
Quantity
14,976 FG cartons
Official record key
drug-enforcement:D-0852-2021

Official wording

Reason: Subpotent Drug

Code information: Lot: 2021-10159 Exp. 06/08/2023

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

Field note

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