Drug recall
Gabapentin Tablets, USP, 800 mg, 500-count, Rx only, Made in India, PONDRUGS/16 134193, Distributed by: Solco…
FDA recall event 78697 · Class II · Solco Healtcare US LLC
Key facts
| Event ID | 78697 |
|---|---|
| Recall numbers | D-0155-2018 |
| Recalling firm | Solco Healtcare US LLC |
| Product type | Drugs |
| Products | Gabapentin Tablets, USP, 800 mg, 500-count, Rx only, Made in India, PONDRUGS/16 134193, Distributed by: Solco Healthcare US, LLC, Cranbury, NJ, 08512, USA. NDC 43547-0333-50 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Labeling: Label Mix-Up.some bottles labeled as Gabapentin 800 mg contain Gabapentin 600 mg |
| Initiation date | Dec 4, 2017 |
| Report date | Jan 17, 2018 |
| Termination date | Feb 25, 2019 |
| City | Cranbury |
| State | NJ |
| Country | United States |
| FEI number | 3007331714 |
At a glance
- 1–9 Products in this recall
- None 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 · Source date: