FDA recall D-1381-2019

Product

Cetirizine Hydrochloride Oral Solution, USP 1mg/mL, Fr Oral Use Only, Rx only, 120 mL bottle, a) NDC 13668-029-07, b) NDC 13668-596-07, Manufactured by Bio-Pharm, Inc. Levittown, PA, For Torrent Pharma Inc., Basking Ridge, NJ 07920..

Reason for recall

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

Distribution

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

Key facts

Status

Terminated

Initiation date

2019-05-21

Report date

2019-06-19

Termination date

2020-10-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Levittown, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1381-2019