FDA recall D-1375-2019

Torrent Pharma Inc · Class II · drug

Product

Memantine Hydrochloride Oral Solution, 2 mg/mL, Rx Only, 12 FL. oz.. bottle, NDC: 13668-573-09, Manufactured By Bio-Pharm Inc., Levittown, PA 19057, Manufactured 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-1375-2019