Drug recall
Avandamet¿ Tablets (rosiglitazone maleate/metformin HCl), 1mg/500mg, 60 and 100 count bottles, Rx only…
FDA recall event 31127 · Class II · Glaxosmithkline
Key facts
| Event ID | 31127 |
|---|---|
| Recall numbers | D-171-5, D-172-5, D-173-5, D-174-5 |
| Recalling firm | Glaxosmithkline |
| Product type | Drugs |
| Products | Avandamet¿ Tablets (rosiglitazone maleate/metformin HCl), 1mg/500mg, 60 and 100 count bottles, Rx only, GlaxoSmithKline, Research Triangle Park, NC ***** 60''s tablets -NDC-0007-3166-18 and 100…, Paxil CR (paroxetine hydrochloride) 37.5 mg Controlled-Release Tablets, 30 count bottles, Rx only, GlaxoSmithKline, Research Triangle Park, NC ***** NDC 0029-3208-29, Paxil CR Tablets (paroxetine HCl) 12.5 mg Controlled-Released Tablets, 30 count bottles and 7 count sample packs, Rx only, GlaxoSmithKline, Research Triangle Park, NC **** NDC 0029-3206-13, Paxil CR Tablets (paroxetine hydrochloride) 25 mg Controlled-Release Tablets, 30 count bottles and 7 count sample packs, Rx only, GlaxoSmithKline, Research Triangle Park, NC ***** NDC 0029-3207-13 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Low-level manufacturing defect may result in the tablets splitting apart and patients not receiving the proper amount of medication., Low-level manufacturing defect that may result in the tablets splitting apart and patients not receiving the proper amount of medication., Superpotency; active ingredient (rosiglitazone maleate) |
| Initiation date | Jan 21, 2005 |
| Termination date | Jul 25, 2012 |
| City | Cidra |
| State | PR |
| Country | United States |
| FEI number | 3004015330 |
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