Class II ยท Moderate risk
Orkambi 200 mg/125 mg Tablets #112 NDC 51167-0809-01 28 days supply.
Lack of Processing Controls.
National Drug Code
Is NDC 51167-0809-01 recalled?
Orkambi · 4 CARTON in 1 BOX (51167-809-01) / 7 BLISTER PACK in 1 CARTON / 4 TABLET, FILM COATED in 1 BLISTER PACK
Yes — this exact package was recalled
1 FDA recall names the code 51167-0809-01 directly. A recall still applies to particular lot numbers — compare the lot on your package with the FDA notice below, and talk to your pharmacist before stopping a prescribed medication.
- Active ingredient
- lumacaftor and ivacaftor
- Strength
- LUMACAFTOR 200 mg/1; IVACAFTOR 125 mg/1
- Form
- Tablet, Film Coated · Oral
- Labeler
- Vertex Pharmaceuticals Incorporated
- Type
- Human Prescription Drug
- Product code
- 51167-0809
Recalls naming this package
Where to find this code. The NDC is printed on the pharmacy label and on the manufacturer's carton, usually as three groups of digits after “NDC”. The last group is the package size — two bottles of the same medicine can differ only in that group, and a recall may cover one but not the other.
Other recalled products from this labeler
- 51167-0200 Kalydeco 1
- 51167-0700 Orkambi 1
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.