Recalls / Class II

Class IID-1380-2019

Product

Cetirizine Hydrochloride Oral Solution, USP 1 mg/mL, For Oral Use Only, Rx Only, 120 mL bottle, NDC 23155-292-51, Mfd for Heritage Pharmaceuticals Inc., Eatontown, NJ 07724.

Affected lot / code info

Lot #s: 17E021; 17E023; 17E040; 17E042, Exp. 05/2019; 17F017, Exp. 06/2019; 17G030; 17G033, Exp. 07/2019; 17H013, Exp. 08/2019; 17J007; 17J024, Exp. 09/2019; 17K003; 17K011, Exp. 10/2019; 17L016; 17L022, Exp. 11/2019; 17M001; 17M021; 17M030, Exp. 12/2019; 18A027; 18A037, Exp. 01/2020; 18B001, Exp. 02/2020; 18C005; 18C006; 18C007, Exp. 03/2020.

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

1,126,404 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-1380-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.