Recalls / Class II

Class IID-1349-2019

Product

Robafen Cough Formula Expectorant (guaifenesin USP 200 mg in each 10 mL), a) 4 Fl. oz. (118 mL) bottle, NDC: 0904-0061-00, b) One Pint ( 473 mL) bottle, NDC: 0904-0061-16, Distributed by Major Pharmaceuticals, Livonia MI 48152.

Affected lot / code info

Lot #s: a) 17F003, Exp. 06/2019; 17J011, Exp. 09/2019; 17K018; 17K020, Exp. 10/2019; 17M014; 17M034, Exp. 12/2019; 18A035; Exp. 01/2020; 18B022; 18B027, Exp. 02/2020; 18C036, Exp. 03/2020; 18D009; 18D024, Exp. 04/2020. b) 17G018, Exp. 07/2019; 17H001; 17H010; 17H014, Exp. 08/2019; 17J009, Exp. 09/2019; 17K023, Exp. 10/2019; 17L006; 17L025, Exp. 11/2019; 17M025; 17M034; Exp. 12/2019; 18A005; 18A012; 18A016, Exp. 01/2020; 18B020, Exp. 02/2020; 18C023; 18C031, Exp. 03/2020; 18E017, Exp. 05/2020; 18G005; 18G022, Exp. 07/2020; 18H021; 18H026, Exp. 08/2020; 18J003Exp. 09/2020.

Why it was recalled

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

Recalling firm

Firm

Torrent Pharma Inc

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

2091 Hartel Ave, N/A, Levittown, Pennsylvania 19057-4506

Distribution

Quantity

984,888 bottles

Distribution pattern

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

Timeline

Recall initiated

2019-05-21

FDA classified

2019-06-13

Posted by FDA

2019-06-19

Terminated

2020-10-06

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1349-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.