Class III · Low risk
Dabigatran Etexilate Capsules
Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
National Drug Code
Is NDC 0904-7255-10 recalled?
Dabigatran Etexilate · 2 BLISTER PACK in 1 CARTON (0904-7255-10) / 10 CAPSULE, COATED PELLETS in 1 BLISTER PACK (0904-7255-35)
Yes — this exact package was recalled
1 FDA recall names the code 0904-7255-10 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
- Major Pharmaceuticals
- Type
- Human Prescription Drug
- Product code
- 0904-7255
Recalls naming this package
Class III · Low risk
Dabigatran etexilate Capsules
Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month Long-Term Stability.
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
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