FDA DrugsClass II
Bromfenac Ophthalmic Solution 0.07%, 3 ml, Rx only, Sterile, Manufactured for: A...
Published: April 8, 2026Category: drugsCountry: US
Reason for Recall / Hazard
Failed Impurities/Degradation Specifications: out of specification at the time of testing i.e. 20th month stability testing.
Product Description & Identification
Bromfenac Ophthalmic Solution 0.07%, 3 ml, Rx only, Sterile, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, Made in India, Manufactured by: Alembic Pharmaceuticals Limited, Karakhadi- 391 450, Gujarat, India NDC 62332-583-03.
Additional Source Details
| Field | Value |
|---|---|
| City | Bedminster |
| State | NJ |
| Openfda › Unii | 8ECV571Y37 |
| Openfda › Route | OPHTHALMIC |
| Openfda › Rxcui | 1375917 |
| Openfda › Spl id | e680d513-20c9-4595-a293-d3f57d24f428 |
| Openfda › Brand name | BROMFENAC SODIUM |
| Openfda › Spl set id | f6911061-d00e-466d-b623-f81730f38f98 |
| Openfda › Package ndc | 62332-583-03 |
| Openfda › Product ndc | 62332-583 |
| Openfda › Generic name | BROMFENAC SODIUM |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name | BROMFENAC SODIUM |
| Openfda › Manufacturer name | Alembic Pharmaceuticals Inc. |
| Openfda › Application number | ANDA214340 |
| Openfda › Is original packager | true |
| Event id | 98647 |
| Address 1 | 550 Hills Dr Ste 104b |
| Code info | Lot # 7240184, 7240185, 7240186, 7240187, Exp Date: 3/31/2026; Lot # 7240278, Exp Date: 5/31/2026. |
| Postal code | 07921-1537 |
| Report date | 20260408 |
| Product type | Drugs |
| Reason for recall | Failed Impurities/Degradation Specifications: out of specification at the time of testing i.e. 20th month stability testing. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260318 |
| Initial firm notification | Letter |
| Center classification date | 20260331 |
Overview
- Recalling FirmALEMBIC PHARMACEUTICALS, INC.
- StatusOngoing
- Risk LevelClass II
- DistributionNationwide in the USA