Beta Labs
FDA Regulatory Profile
Beta Labs appears in FDA public data with 4 recalls — including 1 Class I (most serious) —, 1 510(k) clearance, 0 FDA inspections, and 1 compliance action on record. Its most recent recall (F-2398-2014, Class II) was initiated on June 20, 2013. Its most recent 510(k) clearance was granted on November 28, 1986.
Summary
- Total Recalls
- 4 (1 Class I)
- 510(k) Clearances
- 1
- Inspections
- 0
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| F-2398-2014 | Class II | Oxyphen XR, 12 HR / CLINICAL STRENGTH FAT BURNER, 45 FAST ACTING EXTENDED RELEASE CAPSULES, Distribu | June 20, 2013 |
| F-2400-2014 | Class II | PHEnFX (TM), PHENO 550 mg, PHARMACEUTICAL GRADE, 90 CAPSULES, Manufactured for: Beta Labs, LTD, New | June 20, 2013 |
| F-2401-2014 | Class II | RED VIPERS, ADVANCED FOCUS AND CONCENTRATION, HEIGHTENED ENERGY LEVELS, 75mg EPHEDRA, Manufactured | June 20, 2013 |
| F-2399-2014 | Class I | PHENTALENE (TM), PHARMACEUTICAL GRADE, With 50 mg of Ephedra Extract, 90 CAPSULES, Distributed by Be | June 20, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K864343 | BL1 (HARD CONTACT LENS) | November 28, 1986 |