Dabigatran Etexilate Capsules, 75 mg, 30-count (3x10) blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, NDC 0904-7253-04.
USDabigatran Etexilate Capsules, 75 mg, 30-count (3x10) blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, NDC 0904-7253-04.
Recalling Firm: Ascend Laboratories, LLC
Reason for Recall / Hazard
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
Product Description & Identification
Dabigatran Etexilate Capsules, 75 mg, 30-count (3x10) blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, NDC 0904-7253-04.
Additional Source Details
| Field | Value |
|---|---|
| City | Bedminster |
| State | NJ |
| Openfda › Upc › 1 | 0309047253043 |
| Openfda › Upc › 2 | 0309047255108 |
| Openfda › Unii | SC7NUW5IIT |
| Openfda › Route | ORAL |
| Openfda › Rxcui › 1 | 1037045 |
| Openfda › Rxcui › 2 | 1037179 |
| Openfda › Rxcui › 3 | 1723476 |
| Openfda › Spl id | 869fd2f3-9357-4148-8b64-0cca96dd5f75 |
| Openfda › Brand name | DABIGATRAN ETEXILATE |
| Openfda › Spl set id | b76b79ce-b7dd-4390-b40e-71ae6c477d10 |
| Openfda › Package ndc › 1 | 0904-7253-35 |
| Openfda › Package ndc › 2 | 0904-7253-04 |
| Openfda › Package ndc › 3 | 0904-7253-68 |
| Openfda › Package ndc › 4 | 0904-7254-35 |
| Openfda › Package ndc › 5 | 0904-7254-68 |
| Openfda › Package ndc › 6 | 0904-7255-35 |
| Openfda › Package ndc › 7 | 0904-7255-10 |
| Openfda › Package ndc › 8 | 0904-7255-68 |
| Openfda › Product ndc › 1 | 0904-7253 |
| Openfda › Product ndc › 2 | 0904-7254 |
| Openfda › Product ndc › 3 | 0904-7255 |
| Openfda › Generic name | DABIGATRAN ETEXILATE |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name | DABIGATRAN ETEXILATE MESYLATE |
| Openfda › Manufacturer name | Major Pharmaceuticals |
| Openfda › Application number | ANDA208040 |
| Openfda › Is original packager | true |
| Event id | 99421 |
| Address 1 | 135 Us Highway 202 206 Ste 15 |
| Address 2 | N/A |
| Code info | Lot: 25141586, Exp. April 30, 2027. |
| Postal code | 07921-2608 |
| Report date | 20260805 |
| Product type | Drugs |
| Product quantity | 936 cartons x 12 x 3 x 10 (in blister pack) |
| Reason for recall | 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 |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260716 |
| Initial firm notification | Letter |
| Center classification date | 20260805 |
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Overview
- Recalling FirmAscend Laboratories, LLC
- StatusOngoing
- Risk LevelClass III
- DistributionUSA Nationwide
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🚨 SAFETY ALERT: Ascend Laboratories, LLC - Dabigatran Etexilate Capsules, 75 mg, 30-count (3x10) blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, NDC 0904-7253-04. Check if your household is affected: https://therecallfile.com/recalls/dabigatran-etexilate-capsules-75-mg-30-count-3x10-blister-pack-further/FDA-D-0739-2026
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