D-1377-2019 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- June 19, 2019
- Initiation Date
- May 21, 2019
- Termination Date
- October 6, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 120,204 cartons
Product Description
Laxative Suppositories (Bisacodyl USP, 10 mg), a) 12 Suppositories per carton, NDC: 0536-1355-12, b) 100 Suppositories per carton, NDC: 0536-1355-01, Distributed Rugby Laboratories, Livonia, MI 48152.
Reason for Recall
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Distribution Pattern
Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
Code Information
Lot #s: a) 17K009, Exp. 10/2019; 17M028, Exp. 12/2019; 18F003, Exp. 06/2020; 18J022, Exp. 09/2020; 18L012, Exp. 11/2020; 19A008, Exp. 01/2021. b) 17G004; 17G028, Exp. 07/2019; 18A034, Exp. 01/2020; 18C016, Exp. 03/2020; 18E005, Exp. 05/2020; 18F038, Exp. 06/2020; 18G015, Exp. 07/2020; 18H024, Exp. 08/2020; 18K024, Exp. 10/2020; 18L011, Exp. 11/2020; 19A009, Exp. 01/2021; 18D033, Exp. 04/2020; 18E025, Exp. 05/2020.