Duloxetine Delayed-Release Capsules, 20 mg, Rx Only, 60 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-097-06.
USDuloxetine Delayed-Release Capsules, 20 mg, Rx Only, 60 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-097-06.
Recalling Firm: Ajanta Pharma Ltd.
Motivo del Retiro / Peligro
TranslatedCGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
Descripción del Producto e Identificación
TranslatedDuloxetine Delayed-Release Capsules, 20 mg, Rx Only, 60 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-097-06.
Additional Source Details
| Field | Value |
|---|---|
| City | Aurangabad |
| Openfda › Upc › 1 | 0327241164309 |
| Openfda › Upc › 2 | 0327241099038 |
| Openfda › Upc › 3 | 0327241097065 |
| Openfda › Upc › 4 | 0327241098031 |
| Openfda › Unii | 9044SC542W |
| Openfda › Route | ORAL |
| Openfda › Rxcui › 1 | 596926 |
| Openfda › Rxcui › 2 | 596930 |
| Openfda › Rxcui › 3 | 596934 |
| Openfda › Rxcui › 4 | 616402 |
| Openfda › Spl id | ae1a8c02-c1fc-474a-9411-cebecd99e339 |
| Openfda › Brand name | DULOXETINE |
| Openfda › Spl set id | 2dde979d-b6f8-41d1-96fb-325c75ea3a74 |
| Openfda › Package ndc › 1 | 27241-097-06 |
| Openfda › Package ndc › 2 | 27241-097-10 |
| Openfda › Package ndc › 3 | 27241-097-90 |
| Openfda › Package ndc › 4 | 27241-097-05 |
| Openfda › Package ndc › 5 | 27241-098-03 |
| Openfda › Package ndc › 6 | 27241-098-09 |
| Openfda › Package ndc › 7 | 27241-098-10 |
| Openfda › Package ndc › 8 | 27241-164-30 |
| Openfda › Package ndc › 9 | 27241-099-03 |
| Openfda › Package ndc › 10 | 27241-099-90 |
| Openfda › Package ndc › 11 | 27241-099-40 |
| Openfda › Product ndc › 1 | 27241-097 |
| Openfda › Product ndc › 2 | 27241-098 |
| Openfda › Product ndc › 3 | 27241-164 |
| Openfda › Product ndc › 4 | 27241-099 |
| Openfda › Generic name | DULOXETINE |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name | DULOXETINE HYDROCHLORIDE |
| Openfda › Manufacturer name | Ajanta Pharma USA Inc. |
| Openfda › Application number | ANDA208706 |
| Openfda › Is original packager | true |
| Event id | 98785 |
| Address 1 | B-4/5/6 MIDC Industrial Area |
| Address 2 | Paithan |
| Code info | Lot#: PA10734, Exp. Jun 2026. |
| Postal code | N/A |
| Report date | 20260513 |
| Product type | Drugs |
| Product quantity | 117,168 packs |
| Reason for recall | CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260429 |
| Initial firm notification | Letter |
| Center classification date | 20260504 |
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 Duloxetine Delayed-Release Capsules, 20 mg, Rx Only, 60 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, N...?
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 ResponsableAjanta Pharma Ltd.
- StatusOngoing
- Nivel de RiesgoClass II
- DistributionNationwide within U.S
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🚨 SAFETY ALERT: Ajanta Pharma Ltd. - Duloxetine Delayed-Release Capsules, 20 mg, Rx Only, 60 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-097-06. Check if your household is affected: https://therecallfile.com/es/recalls/duloxetine-delayed-release-capsules-20-mg-rx-only-60-capsules-marketed/FDA-D-0516-2026
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