Drug recall
Betaxolol Tablets USP, 10 mg, Rx only, 100 count bottles Amide Pharmaceuticals, Little Falls, NJ 07424/Actavis…
FDA recall event 49023 · Class II · Actavis Totowa LLC
Key facts
| Event ID | 49023 |
|---|---|
| Recall numbers | D-055-2009, D-056-2009, D-057-2009, D-058-2009, D-059-2009, D-060-2009, D-061-2009, D-062-2009, D-063-2009, D-064-2009, D-065-2009, D-066-2009 and 38 more |
| Recalling firm | Actavis Totowa LLC |
| Product type | Drugs |
| Products | Betaxolol Tablets USP, 10 mg, Rx only, 100 count bottles Amide Pharmaceuticals, Little Falls, NJ 07424/Actavis Totowa LLC, Totowa, NJ 07512 --- Also labeled as Kerlone (Be tazolol Hydrochloride)…, Betaxolol Tablets USP, 20 mg, Rx only, 100 count bottles Amide Pharmaceuticals, Little Falls, NJ 07424/Actavis Totowa LLC, Totowa, NJ 07512 Also labeled as Kerlone (Betaxolol Hydrochloride)…, Buspirone Hydrochloride Tablets, USP, 10 mg, Rx only, 100 and 500 count bottles, Amide Pharmaceuticals, Little Falls, NJ/Actavis Totowa LLC, Totowa, NJ. Also labeled for Major Pharmaceuticals. 100…, Buspirone Hydrochloride Tablets, USP, 15 mg, Rx only, 100, 180 and 250 count bottles, Amide Pharmaceuticals, Little Falls, NJ/Actavis Totowa LLC, Totowa, NJ Also labeled for Major Pharmaceuticals, 100…, BusPIRone Hydrochloride Tablets, USP, 30 mg, Rx only, 60 and 180 Tablets, Actavis, Totowa, NJ. and 45 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | cGMP Deviations |
| Initiation date | Jun 25, 2008 |
| Termination date | Jan 15, 2013 |
| City | Totowa |
| State | NJ |
| Country | United States |
| FEI number | 2244683 |
At a glance
- 10–99 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