Recalls / Class II
Class IID-1373-2019
Product
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.
- Affected 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.
Why it was recalled
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Recalling firm
- Firm
- Torrent Pharma Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2091 Hartel Ave, N/A, Levittown, Pennsylvania 19057-4506
Distribution
- Quantity
- 153.540 bottles
- Distribution pattern
- Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
Timeline
- Recall initiated
- 2019-05-21
- FDA classified
- 2019-06-13
- Posted by FDA
- 2019-06-19
- Terminated
- 2020-10-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1373-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.