FDAFDA · Food and drugs·Recall number D-1382-2019
RisperiDONE Oral Solution, USP, 1 mg/mL, Rx Only, 30 mL bottle, NDC 23155-317-51, Mfd for Heritage Pharmaceuticals Inc., East Brunswick, NJ 08816.
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: 17F012; 17F012A, Exp. 06/2019; 17G031, Exp. 07/2019; 17H004; 17H031, Exp. 08/2019; 18B004, Exp. 02/2020; 18C028, Exp. 03/2020
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.