FDA DrugsClass II
Duloxetine DR Capsules, 30 mg, 30 count bottles, Rx, Relabeled by: Enovachem Pha...
Published: June 10, 2026Recall ID: D-0555-2026Category: drugsCountry: US
Reason for Recall / Hazard
CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.
Product Description & Identification
Duloxetine DR Capsules, 30 mg, 30 count bottles, Rx, Relabeled by: Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-634-30, Marketed by: Ajanta Pharma USA Inc.
Additional Source Details
| Field | Value |
|---|---|
| City | Torrance |
| State | CA |
| 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 | 31e2603c-b629-1f0d-e063-6294a90a3646 |
| Openfda › Brand name | DULOXETINE |
| Openfda › Spl set id | f61bd9f3-cd3d-4c76-a110-0f1dcba610af |
| Openfda › Package ndc › 1 | 76420-633-20 |
| Openfda › Package ndc › 2 | 76420-633-30 |
| Openfda › Package ndc › 3 | 76420-633-60 |
| Openfda › Package ndc › 4 | 76420-633-90 |
| Openfda › Package ndc › 5 | 76420-633-01 |
| Openfda › Package ndc › 6 | 76420-633-05 |
| Openfda › Package ndc › 7 | 76420-633-00 |
| Openfda › Package ndc › 8 | 76420-634-20 |
| Openfda › Package ndc › 9 | 76420-634-30 |
| Openfda › Package ndc › 10 | 76420-634-60 |
| Openfda › Package ndc › 11 | 76420-634-90 |
| Openfda › Package ndc › 12 | 76420-634-01 |
| Openfda › Package ndc › 13 | 76420-634-00 |
| Openfda › Package ndc › 14 | 76420-636-20 |
| Openfda › Package ndc › 15 | 76420-636-30 |
| Openfda › Package ndc › 16 | 76420-636-60 |
| Openfda › Package ndc › 17 | 76420-636-90 |
| Openfda › Package ndc › 18 | 76420-636-01 |
| Openfda › Package ndc › 19 | 76420-623-20 |
| Openfda › Package ndc › 20 | 76420-623-30 |
| Openfda › Package ndc › 21 | 76420-623-60 |
| Openfda › Package ndc › 22 | 76420-623-90 |
| Openfda › Package ndc › 23 | 76420-623-01 |
| Openfda › Package ndc › 24 | 76420-623-00 |
| Openfda › Product ndc › 1 | 76420-623 |
| Openfda › Product ndc › 2 | 76420-633 |
| Openfda › Product ndc › 3 | 76420-634 |
| Openfda › Product ndc › 4 | 76420-636 |
| Openfda › Generic name | DULOXETINE |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name | DULOXETINE HYDROCHLORIDE |
| Openfda › Manufacturer name | Asclemed USA, Inc. |
| Openfda › Application number | ANDA208706 |
| Openfda › Original packager product ndc › 1 | 27241-097 |
| Openfda › Original packager product ndc › 2 | 27241-098 |
| Openfda › Original packager product ndc › 3 | 27241-164 |
| Openfda › Original packager product ndc › 4 | 27241-099 |
| Event id | 99019 |
| Address 1 | 379 Van Ness Ave Ste 1403 |
| Code info | Lot # 050725G-30 & 050725F-30, Exp Date: 06/30/2026 |
| Postal code | 90501-7211 |
| Report date | 20260610 |
| Product type | Drugs |
| Product quantity | 50 bottles |
| Reason for recall | CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260514 |
| Initial firm notification | Letter |
| Center classification date | 20260602 |
Overview
- Recalling FirmAsclemed USA Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide.