Lactulose Solution, USP 10 g/15 mL, For Oral Administration, Rx Only, a) 16 FL. oz., NDC: 13668-580-10, b) 32 FL. oz., NDC: 13668-580-12, Manufactured by Bio-Pharm Inc., Levittown PA 19057, Manufactured for Torrent Pharma Inc., Basking Ridge, NJ 07920.

Class I - Dangerous

💊 Drugs Recalled: May 21, 2019 Torrent Pharma Prescription Drugs

What Should You Do?

Check if you have this product:
Lot #s: a) 18K025; 18K027, Exp. 10/2020; 18L001; 18L006; 18L007, Exp. 11/2020; 18M013, Exp. 12/2020; 19A006, Exp. 01/2021. b) 18K027, Exp. 10/2020; 19A006, Exp. 01/2021.
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: Torrent Pharma Inc
Reason for Recall:: cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: terminated

Product Information

Full Description:

Lactulose Solution, USP 10 g/15 mL, For Oral Administration, Rx Only, a) 16 FL. oz., NDC: 13668-580-10, b) 32 FL. oz., NDC: 13668-580-12, Manufactured by Bio-Pharm Inc., Levittown PA 19057, Manufactured for Torrent Pharma Inc., Basking Ridge, NJ 07920.

Product Codes/Lot Numbers:

Lot #s: a) 18K025; 18K027, Exp. 10/2020; 18L001; 18L006; 18L007, Exp. 11/2020; 18M013, Exp. 12/2020; 19A006, Exp. 01/2021. b) 18K027, Exp. 10/2020; 19A006, Exp. 01/2021.