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.

D-1375-2019

May 21, 2019

Class II

Product summary

Firm: Torrent Pharma Inc
Event: Event 82889
Status: Terminated
Classification: Class II
Quantity: 264 bottles
Official record key: drug-enforcement:D-1375-2019

Official wording

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

Code information: Lot #: 18F026, Exp. 06/2020.

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

Derived failure modes

Manufacturing or process control
reason.manufacturing_process_control · v1.0.0

cGMP Deviations
Microbial contamination
reason.microbial_contamination · v1.0.0

contamination with Burkholderia cepacia (B.cepacia) and Ralstonia