Drug product
Bisacodyl Suppositories, Brite Stock, Reese.
D-1385-2019
Product summary
- 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
cGMP Deviations
-
Microbial contamination
contamination with Burkholderia cepacia (B.cepacia) and Ralstonia