Robafen DM Cough Sugar-Free Clear Cough Expectorant (Dextromethorphan HBr, USP 20 mg), Expectorant (Guaifenesin, USP 200 mg in each 2 teaspoonfuls (10mL)), 4 Fl. oz. (118 mL) bottle, NDC: 0904-6306-20, Distributed by Major Pharmaceuticals, Livonia MI 48152.

Reason: cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Code information: Lot #s: 17E016; 17E017, Exp. 05/2019; 17F023; 17F023A, Exp. 06/2019; 17L018; 17L029; 17L030; 17L031, Exp. 11/2019; 17M035, Exp. 12/2019; 18B002; 18B014; 18B035, Exp. 02/2020; 18C002; 18C019, Exp. 03/2020; 18D013, Exp. 04/2020.

Distribution pattern: Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.