Recalls / Class II
Class IID-1357-2019
Product
Biscolax Laxative (Bisacodyl, USP 10 mg), a) 12 suppositories per carton, NDC: 0904-5058-12, b) 100 suppositories per carton, NDC: 0904-5058-60, Distributed by Major Pharmaceuticals Inc., Livonia MI 48152.
- Affected lot / code info
- Lot #s: a) 17E004; 17E033, Exp. 05/2019; 17F019, Exp. 06/2019; 17G017, Exp. 07/2019; 17K009; 17K030; Exp. 10/2019, 17M006; 17M028, Exp. 12/2019; 18A029, Exp. 01/2020; 18C037, Exp. 03/2020; 18E002, Exp. 05/2020; 18F003; 18F013, Exp. 06/2020; 18G002; 18G016, Exp. 07/2020; 18H031, Exp. 08/2020; 18J004, 09/2020; 18L008; 18L012, Exp. 11/2020; 19A008, Exp. 01/2021. b) 17E005; 17E027, Exp. 05/2019; 17K025, Exp. 10/2019; 17M006, Exp. 12/2019; 18A014, Exp. 01/2020; 18B039, Exp. 02/2020; 18C037, Exp. 03/2020; 18D033, Exp. 04/2020; 18E025, Exp. 05/2020; 18F013; 18F018, Exp. 06/2020; 18G003, Exp. 07/2020; 18H012; 18H014, Exp. 08/2020; 18J026, Exp. 09/2020; 18L009, Exp. 11/2020; 18M014, Exp. 12/2020; 19A021, Exp. 01/2021; 19B001; 19B002, Exp. 02/2021.
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
- 391,404 cartons
- 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-1357-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.