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Recall Observatory FDA recall evidence

Drug product

Nasal Decongestant Liquid, Pseudoephedrine HCl, 30 mg in each teaspoonful, 4 Fl. oz. (118 mL) bottle, NDC:0536-1850-97, Distributed by Rugby Laboratories, Livonia MI 48152.

D-1371-2019

May 21, 2019

Class II

Product summary

Firm
Torrent Pharma Inc
Event
Event 82889
Status
Terminated
Classification
Class II
Quantity
62,748 bottles
Official record key
drug-enforcement:D-1371-2019

Official wording

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

Code information: Lot #s: 17G002, Exp. 07/2019; 17H024, Exp. 08/2019; 17M023, Exp. 12/2019; 18F012, Exp. 06/2020.

Distribution pattern: Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.

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