Torrent Pharma Inc recalls Memantine Hydrochloride Oral Solution, 2 mg/mL, Rx Only, 12 FL. oz.. bottle, NDC: 13668-573-09, Manufactured By Bio-Phar
Recalled June 19, 2019 · FDA recall D-1375-2019 · Torrent Pharma
Hazard
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). · FDA Class II
Units
264 bottles
Sold at
Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
Description
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
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.
Manufacturer(s)
Torrent Pharma Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →