Dabigatran etexilate Capsules, 110 mg, 60-count carton (6x10), Rx Only, Manufactured by: Alkem Laboratories, Mumbai, INDIA, Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7254-68.
USDabigatran etexilate Capsules, 110 mg, 60-count carton (6x10), Rx Only, Manufactured by: Alkem Laboratories, Mumbai, INDIA, Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7254-68.
Recalling Firm: Ascend Laboratories, LLC
Motivo del Retiro / Peligro
TranslatedFailed 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.
Descripción del Producto e Identificación
TranslatedDabigatran etexilate Capsules, 110 mg, 60-count carton (6x10), Rx Only, Manufactured by: Alkem Laboratories, Mumbai, INDIA, Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7254-68.
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 | 99330 |
| Address 1 | 135 Us Highway 202 206 Ste 15 |
| Address 2 | N/A |
| Code info | Lot: 25141707, Exp 4/30/2027. |
| Postal code | 07921-2608 |
| Report date | 20260729 |
| Product type | Drugs |
| Product quantity | 1,753 cartons |
| Reason for recall | 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260630 |
| Initial firm notification | Letter |
| Center classification date | 20260804 |
Consumer Action Protocol: What You Should Do Immediately
Safety StepsInspect the NDC code, batch number, or control number on your medicine bottle or blister packaging to confirm whether your unit is included.
Do not abruptly stop critical prescribed medication without physician advice. Contact your dispensing pharmacist immediately for a safe alternative.
Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.
If you suffered an injury, illness, or property damage from this product, file an official incident report with regulatory authorities (FDA Drugs).
Your Legal Rights as a Consumer
Recalls are legally binding corrective safety actions overseen by statutory government bodies. Recalling entities are legally prohibited from charging consumers for official safety remedies. If a retailer or dealership refuses your recall remedy, notify the issuing regulatory agency immediately.
Frequently Asked Questions About This Recall
FAQ GuideQ1:What should I do immediately if I own or bought Dabigatran etexilate Capsules, 110 mg, 60-count carton (6x10), Rx Only, Manufactured by: Alkem Laboratories, Mumbai,...?
Check the lot number and NDC on your prescription label. For essential medications, consult your doctor or dispensing pharmacist immediately before abruptly stopping your dose.
Q2:Can I get a full refund or free repair for this recall?
Yes. Recalling manufacturers and retail merchants are required under consumer protection regulations to offer a statutory remedy—typically a full refund, certified repair kit, or replacement unit.
Q3:Do I need my original sales receipt to claim a remedy or refund?
In most recall cases, no receipt is required. Because safety recalls are matters of public health and statutory compliance, retailers and manufacturers routinely issue refunds, store credit, or replacement kits upon presentation of the affected product or lot code.
Q4:Where can I verify official information for this safety alert?
This safety alert is aggregated directly from official regulatory agency records (FDA Drugs). You can click the 'Official Agency Alert' link on this page to view the primary government notice and contact the manufacturer directly.
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Resumen
- Empresa ResponsableAscend Laboratories, LLC
- StatusOngoing
- Nivel de RiesgoClass III
- DistributionUSA Nationwide
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🚨 SAFETY ALERT: Ascend Laboratories, LLC - Dabigatran etexilate Capsules, 110 mg, 60-count carton (6x10), Rx Only, Manufactured by: Alkem Laboratories, Mumbai, INDIA, Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7254-68. Check if your household is affected: https://therecallfile.com/es/recalls/dabigatran-etexilate-capsules-110-mg-60-count-carton-6x10-rx-only-manu/FDA-D-0735-2026
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