RecallRadar

FDA Drug recall D-1374-2019

Memantine Hydrochloride Oral Solution, 2 mg/mL, 12 oz. bottle, NDC: 39328-551-12, Patrin Pharma

On 2019-06-19 the FDA classified a Class II recall of Memantine Hydrochloride Oral Solution, 2 mg/mL, 12 oz. bottle, NDC: 39328-551-12, Patrin Pharma by Torrent Pharma, citing cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-1374-2019
ClassificationClass II
Statusterminated
Initiated2019-05-21
Published2019-06-19
Last updated2026-09-13 11:52 UTC
CompanyTorrent Pharma
DistributionUS

Product

Memantine Hydrochloride Oral Solution, 2 mg/mL, 12 oz. bottle, NDC: 39328-551-12, Patrin Pharma

Reason

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

Identifiers

code_infoLot #s: 17E001, Exp. 05/2019; 17F014, Exp. 06/2019; 17G005; 17G010, Exp. 07/2019; 17J019; 17J021, Exp. 09/2019; 17M008; 17M009, Exp. 12/2019.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1374-2019%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.