Robafen AC Oral Solution (Guaifenesin and Codeine Phosphate Oral Solution, USP) 100 mg/10 mg per 5 mL, One Pint (473 mL) bottle, NDC:0904-6479-16, Distributed by Major Pharmaceuticals Inc., Livonia MI 48152.

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

Code information: Lot #s: 17M003, Exp. 12/2019; 18A009; 18A010, Exp. 01/2020; 18B024, Exp. 02/2020; 18F021; Exp. 06/2020; 18G009; 18G020, Exp. 07/2020; 18K005; 18K011; Exp. 10/2020.

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