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FDAFDA · Food and drugs·Recall number D-1374-2019

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

Published June 19, 2019 · Recall initiated: May 21, 2019

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Torrent Pharma Inc
Distributor
Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
Lot
Lot #s: 17E001, Exp. 05/2019; 17F014, Exp. 06/2019; 17G005; 17G010, Exp. 07/2019; 17J019; 17J021, Exp. 09/2019; 17M008; 17M009, Exp. 12/2019.
Risk classification
Class II
Area (FDA)
drug
Country
United States

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