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Recall Observatory FDA recall evidence

Drug product

Robafen DM, Generic for Robitussin DM, In each teaspoonful (5mL): Dextromethorphan HBr, USP 10mg,/Guaifenesin, USP 100mg, 118mL (4oz) bottle, Manufactured for Preferred Pharmaceuticals, Inc., Anaheim, CA 92807 by Major Pharmaceuticals, Livonia, MI 48152, NDC 68788-0841-01

D-1410-2019

June 10, 2019

Class II

Product summary

Firm
Preferred Pharmaceuticals, Inc
Event
Event 83101
Status
Terminated
Classification
Class II
Quantity
192 4 oz bottles
Official record key
drug-enforcement:D-1410-2019

Official wording

Reason: CGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Code information: Lot: J0218L, Batch: 10021812, Exp. 02/2020; Lot: L2718D, Batch numbers from consecutively from L2718D001 to L2718D096, Exp. 07/2020

Distribution pattern: Distribution was made to CA and FL.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations
  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    contamination with Burkholderia cepacia (B.cepacia) and Ralstonia