Drug product
Kid Kare Childrens Cough/Cold Liquid, Antihistamine, Cough Suppressant, Nasal Decongestant, Cherry Flavored, Alcohol Free, (Chlorpheniramine Maleate, USP 2 mg, Dextromethorphan HBr, USP 10 mg, Pseudoephedrine HCl, USP 30 mg in each 2 tsp (10mL)), 4 Fl. oz. bottle, NDC: 0536-2310-97, Distributed by Rugby Laboratories, Livonia MI 48152.
D-1367-2019
Product summary
- Event
- Event 82889
- Status
- Terminated
- Classification
- Class II
- Quantity
- 66,060 bottles
- Official record key
drug-enforcement:D-1367-2019
Official wording
Reason: cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Code information: Lot #s: 17E009, Exp. 05/2019; 17L004; 17L004A, 17L020, Exp. 11/2019; 17M029, Exp. 12/2019; 18C010; 18C025, Exp. 03/2020; 18J020, Exp. 09/2020.
Distribution pattern: Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
Derived failure modes
-
Manufacturing or process control
cGMP Deviations
-
Microbial contamination
contamination with Burkholderia cepacia (B.cepacia) and Ralstonia