Drug recall
Lactulose Solution USP, 10 g/15 mL, 32 fl oz (946 mL) bottle, Rx only, PAI, Pharmaceutical Associates, Inc…
FDA recall event 58647 · Class III · Pharmaceutical Associates Inc
Key facts
| Event ID | 58647 |
|---|---|
| Recall numbers | D-574-2011 |
| Recalling firm | Pharmaceutical Associates Inc |
| Product type | Drugs |
| Products | Lactulose Solution USP, 10 g/15 mL, 32 fl oz (946 mL) bottle, Rx only, PAI, Pharmaceutical Associates, Inc., Greenville, SC 29605, NDC #0121-0577-32, UPC 3 0121-0577-32 1. |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | CGMP Deviations: A deviation in the production process, specifically the packaging operation, could have compromised the integrity of the drug product. |
| Initiation date | Apr 25, 2011 |
| Termination date | Jun 21, 2012 |
| City | Greenville |
| State | SC |
| Country | United States |
| FEI number | 1017687 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports