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Recall Observatory FDA recall evidence

Drug product

Bisacodyl Suppositories, Brite Stock, Reese.

D-1385-2019

May 21, 2019

Class II

Product summary

Firm
Torrent Pharma Inc
Event
Event 82889
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
drug-enforcement:D-1385-2019

Official wording

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

Code information: Lot #s: 17J003, Exp. 09/2019; 18A026, Exp. 01/2020; 18E031, Exp. 05/2020.

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