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Recall Observatory FDA recall evidence

Drug product

NEOGEN-D (Dextromethorphan HBr, 30 mg; Guaifenesin, 200 mg; Phenylephrine HCl, 7.5 mg) in each 5 mL tsp, Raspberry Flavor, 16 fl oz (473 mL) bottle, Manufactured in the USA for Kramer Novis, San Juan, PR 00917, NDC 52083-699-16.

D-1506-2019

June 21, 2019

Class II

Product summary

Firm
Pharma-Natural Inc.
Event
Event 83190
Status
Terminated
Classification
Class II
Quantity
2052 bottles
Official record key
drug-enforcement:D-1506-2019

Official wording

Reason: CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.

Code information: All lots remaining within expiry.

Distribution pattern: Consignees in FL and TX who may have further distributed Nationwide in the USA and Puerto Rico.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations