Recalls / Class II

Class IID-1368-2019

Product

Cough Syrup (Guaifenesin Syrup, USP) 200 mg/10 mL, Alcohol free Non-Narcotic Expectorant, One Pint (473 mL) oz. bottle, NDC: 0536-0825-85, Distributed by Rugby Laboratories, Livonia, MI 48152.

Affected lot / code info

Lot #s: 17F022, Exp. 06/2019; 17G027, Exp. 07/2019; 17H021; 17H021A, Exp. 08/2019; 17J008, Exp. 09/2019; 17L001, Exp. 11/2019; 17M015, Exp. 12/2019; 18A018, Exp. 01/2020; 18B003; 18B008, Exp. 02/2020; 18C012, Exp. 03/2020; 18D005, Exp. 04/2020; 18F008; 18F043, Exp. 06/2020; 18G025; 18H004, Exp. 07/2020; 18H007; 18H016, Exp. 08/2020.

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

249,744 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-1368-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.