FDAFDA · Food and drugs·Recall number D-1373-2019
Lactulose Solution, USP 10 g/15 mL, For Oral or Rectal Administration, Rx Only, 16 FL. oz. Bottle, NDC:13668-574-10, Manufactured By Bio-Pharm, Levittown, PA 19057, Manufactured for Torrent Pharma Inc., Basking Ridge, NJ 07920.
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: 18E016; 18E029, Exp. 05/2020; 18F004; 18F005; 18F039, Exp. 06/2020; 18G010; 18G017, Exp. 07/2020; 18H019, Exp. 08/2020; 18M008, Exp. 12/2020; 19A005, Exp. 01/2021; 19B010, Exp. 02/2021.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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