D-1380-2019 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
- 1,126,404 bottles
Product Description
Cetirizine Hydrochloride Oral Solution, USP 1 mg/mL, For Oral Use Only, Rx Only, 120 mL bottle, NDC 23155-292-51, Mfd for Heritage Pharmaceuticals Inc., Eatontown, NJ 07724.
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: 17E021; 17E023; 17E040; 17E042, Exp. 05/2019; 17F017, Exp. 06/2019; 17G030; 17G033, Exp. 07/2019; 17H013, Exp. 08/2019; 17J007; 17J024, Exp. 09/2019; 17K003; 17K011, Exp. 10/2019; 17L016; 17L022, Exp. 11/2019; 17M001; 17M021; 17M030, Exp. 12/2019; 18A027; 18A037, Exp. 01/2020; 18B001, Exp. 02/2020; 18C005; 18C006; 18C007, Exp. 03/2020.