Azelaic Acid Gel, 15%, 50 gram tubes, For Topical Use only, Rx only, Distributed by: Glenmark Pharmaceuticals Inc., USA, Elmwood Park, NJ 07407, NDC 68462-626-52.
USAzelaic Acid Gel, 15%, 50 gram tubes, For Topical Use only, Rx only, Distributed by: Glenmark Pharmaceuticals Inc., USA, Elmwood Park, NJ 07407, NDC 68462-626-52.
Recalling Firm: Glenmark Pharmaceuticals Inc., USA
Reason for Recall / Hazard
CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received.
Product Description & Identification
Azelaic Acid Gel, 15%, 50 gram tubes, For Topical Use only, Rx only, Distributed by: Glenmark Pharmaceuticals Inc., USA, Elmwood Park, NJ 07407, NDC 68462-626-52.
Additional Source Details
| Field | Value |
|---|---|
| City | Elmwood Park |
| State | NJ |
| Openfda › Nui › 1 | N0000008841 |
| Openfda › Nui › 2 | N0000009982 |
| Openfda › Upc | 0368462626528 |
| Openfda › Unii | F2VW3D43YT |
| Openfda › Route | TOPICAL |
| Openfda › Rxcui | 1041518 |
| Openfda › Spl id | 28cca0c1-2f38-4fa2-8aaf-d3c8978b0fc6 |
| Openfda › Brand name | AZELAIC ACID |
| Openfda › Spl set id | 0b5ab22e-c78a-4429-9a76-a4ba2d11fcde |
| Openfda › Package ndc | 68462-626-52 |
| Openfda › Product ndc | 68462-626 |
| Openfda › Generic name | AZELAIC ACID |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Pharm class pe › 1 | Decreased Protein Synthesis [PE] |
| Openfda › Pharm class pe › 2 | Decreased Sebaceous Gland Activity [PE] |
| Openfda › Substance name | AZELAIC ACID |
| Openfda › Manufacturer name | Glenmark Pharmaceuticals Inc., USA |
| Openfda › Application number | ANDA204637 |
| Openfda › Is original packager | true |
| Event id | 99490 |
| Address 1 | 619 River Dr |
| Address 2 | N/A |
| Code info | Lot #: 19260937A, Exp. Date February 2028; 19261225A, 19261185A, Exp. Date March 2028; 19261664A, 19261682A, Exp. Date April 2028. |
| Postal code | 07407-1317 |
| Report date | 20260805 |
| Product type | Drugs |
| Product quantity | N/A |
| Reason for recall | CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260723 |
| Initial firm notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Center classification date | 20260728 |
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Overview
- Recalling FirmGlenmark Pharmaceuticals Inc., USA
- StatusOngoing
- Risk LevelClass II
- DistributionNationwide within the United States.
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🚨 SAFETY ALERT: Glenmark Pharmaceuticals Inc., USA - Azelaic Acid Gel, 15%, 50 gram tubes, For Topical Use only, Rx only, Distributed by: Glenmark Pharmaceuticals Inc., USA, Elmwood Park, NJ 07407, NDC 68462-626-52. Check if your household is affected: https://therecallfile.com/recalls/azelaic-acid-gel-15-50-gram-tubes-for-topical-use-only-rx-only-distrib/FDA-D-0731-2026
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