Memantine Hydrochloride Oral Solution, 2 mg/mL, 12 oz. bottle, NDC: 39328-551-12, Patrin Pharma
Recall Number: D-1374-2019
Firm: Torrent Pharma Inc
Classification: Class II
Status: Terminated
Report Date: 20190619
Initiation Date: 20190521
Termination Date: 20201006
Reason for Recall
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Product Description
Memantine Hydrochloride Oral Solution, 2 mg/mL, 12 oz. bottle, NDC: 39328-551-12, Patrin Pharma