D-1361-2019 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
- 361,260 bottles
Product Description
Cetirizine HCL Oral Solution, USP 1mg/mL, 4 oz - BULK, PLD
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: 17E015; 17E024; 17E044, Exp. 05/2019; 17F018, Exp. 06/2019; 17G012, Exp. 07/2019; 17K024, Exp. 10/2019; 17M004, Exp. 12/2019; 18B017, Exp. 02/2020; 18H023, Exp. 08/2020.