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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