Class II · Moderate risk
Dabigatran Etexilate
CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
National Drug Code
Is NDC 67877-0475-60 recalled?
Dabigatran Etexilate · 60 CAPSULE, COATED PELLETS in 1 BOTTLE (67877-475-60)
Yes — this exact package was recalled
2 FDA recalls name the code 67877-0475-60 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.
2 of these recalls are still ongoing.
- Active ingredient
- Dabigatran Etexilate
- Strength
- DABIGATRAN ETEXILATE MESYLATE 150 mg/1
- Form
- Capsule, Coated Pellets · Oral
- Labeler
- Ascend Laboratories, LLC
- Type
- Human Prescription Drug
- Product code
- 67877-0475
Recalls naming this package
Class II · Moderate risk
Dabigatran Etexilate 150mg Capsules
CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.
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
- 67877-0545 Cephalexin 4
- 67877-0544 Cephalexin 3
- 67877-0590 Metoprolol Succinate 3
- 67877-0446 Olmesartan Medoxomil 2
- 67877-0474 Dabigatran Etexilate 2
- 67877-0501 Amlodipine and olmesartan Medoxomil 2
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