Torrent Pharma Inc Recall: Lactulose Solution, USP 10 g/15 mL, For Oral or Rectal Administ
Torrent Pharma Inc Recall: Lactulose Solution, USP 10 g/15 mL, For Oral or Rectal Administ is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Torrent Pharma Inc; Product: Lactulose Solution, USP 10 g/15 mL, For Oral or Rectal Administration, Rx Only, 16 FL. oz. Bottle, NDC:13668-574-10, M
| Recalling firm | Torrent Pharma Inc |
|---|---|
| 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. |
| Reason for recall | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States. |
| Recall initiated | 20190521 |
| Recall number | D-1373-2019 |
| Category | drug |
| State | PA |
| Country | United States |
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