Drug product
Cetirizine Oral Solution 1 mg/mL, Children's Allergy, Antihistamine, Dye Free, Grape Flavor, 4 FL. oz. Bottle, Distributed by C.D.M.A. Inc., Novi, MI 48376, Quality Choice, NDC 63868-430-04, UPC 635515992474.
D-1408-2019
Product summary
- Event
- Event 83181
- Status
- Terminated
- Classification
- Class II
- Quantity
- 17,664 bottles
- Official record key
drug-enforcement:D-1408-2019
Official wording
Reason: cGMP Deviations: Firm was notified by their supplier of Cetirizine HCL Oral Solution, USP, 1mg/mL, 4oz, of the voluntary recall that they have initiated due to potential contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Code information: Lot #s: C04866; C09863, Exp. 10/19; F01267, Exp. 12/19; F12609, Exp. 2/20; F25327, Exp. 8/20.
Distribution pattern: Nationwide in the U.S.
Derived failure modes
-
Manufacturing or process control
cGMP Deviations
-
Microbial contamination
contamination with Burkholderia cepacia (B.cepacia) and Ralstonia