Class II
Terminated
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.
This recall has been terminated (originally issued June 19, 2019).
- Company
- Torrent Pharma Inc
- Recall Initiated
- May 21, 2019
- Posted
- June 19, 2019
- Recall Number
- D-1373-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 153.540 bottles
- Firm Location
- Levittown, PA, United States
- Official Source
- View on FDA website ↗
Reason for Recall
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Distribution
Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
Lot / Code Info
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.
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