Recalls / Class II
Class IID-1385-2019
Product
Bisacodyl Suppositories, Brite Stock, Reese.
- Affected lot / code info
- Lot #s: 17J003, Exp. 09/2019; 18A026, Exp. 01/2020; 18E031, Exp. 05/2020.
Why it was recalled
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Recalling firm
- Firm
- Torrent Pharma Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2091 Hartel Ave, N/A, Levittown, Pennsylvania 19057-4506
Distribution
- Quantity
- N/A
- Distribution pattern
- Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
Timeline
- Recall initiated
- 2019-05-21
- FDA classified
- 2019-06-13
- Posted by FDA
- 2019-06-19
- Terminated
- 2020-10-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1385-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.