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Recall Observatory FDA recall evidence

Drug product

G-Supress DX (Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl) Pediatric Drops Cough Suppressant Expectorant Nasal Decongestant, Cherry Flavor Sugar & Alcohol Free, packaged in a bottle Net Content: 30 mL (1 oz.) further packaged in a carton, Manufactured in the USA for Kramer Novis, San Juan, PR 00917, NDC 52083-655-01

D-0868-2023

April 20, 2023

Class I

Product summary

Firm
Novis PR, LLC dba Kramer Novis
Event
Event 92324
Status
Terminated
Classification
Class I
Quantity
9077 bottles
Official record key
drug-enforcement:D-0868-2023

Official wording

Reason: Product mix-up: incorrect product was found inside the G-Supress DX product carton.

Code information: Lot: D20911, Exp. Oct/25

Distribution pattern: Puerto Rico

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Product mix-up: incorrect product was found inside the G-Supress DX product carton.