FDA DrugsClass II
prednisoLONE Acetate Ophthalmic Suspension, USP, 1%, Rx only, Sterile, a) 5 mL (...
Published: July 8, 2026Recall ID: D-0655-2026Category: drugsCountry: US
Reason for Recall / Hazard
Presence of Foreign Substance
Product Description & Identification
prednisoLONE Acetate Ophthalmic Suspension, USP, 1%, Rx only, Sterile, a) 5 mL (NDC 70748-332-02); b) 10 mL (NDC 70748-332-03), c) 15 mL (70748-332-04), Manufactured by: Lupin Limited, Pithampur (M.P) 454 775, INDIA
Additional Source Details
| Field | Value |
|---|---|
| City | Naples |
| State | FL |
| Openfda › Unii | 8B2807733D |
| Openfda › Route | OPHTHALMIC |
| Openfda › Rxcui | 1376336 |
| Openfda › Spl id | 8b7144d6-fff1-4afd-a80b-332ff7ed80a1 |
| Openfda › Brand name | PREDNISOLONE ACETATE |
| Openfda › Spl set id | 75fbeab1-ce8d-4999-a875-472174be5cc6 |
| Openfda › Package ndc › 1 | 70748-332-03 |
| Openfda › Package ndc › 2 | 70748-332-02 |
| Openfda › Package ndc › 3 | 70748-332-04 |
| Openfda › Product ndc | 70748-332 |
| Openfda › Generic name | PREDNISOLONE ACETATE |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name | PREDNISOLONE ACETATE |
| Openfda › Manufacturer name | Lupin Pharmaceuticals, Inc. |
| Openfda › Application number | ANDA216935 |
| Openfda › Is original packager | true |
| Event id | 99144 |
| Address 1 | 5801 Pelican Bay Blvd Ste 500 |
| Address 2 | N/A |
| Code info | Lots: a) HA00937, HA00939, HA00941, HA00971, H00973, HA00975, Expires: 7/31/2026; HA00987, HA00989, HA00991, HA01010, HA01012, HA01014, HA01016, HA01048, Expires: 8/31/2026; HA01120, HA01137, HA01129, HA01138, HA01133, Expires: 9/30/2026; HA01148, HA01196, HA01198, HA01200, HA01206, HA01208, HA01210, HA01212, HA01214, HA01216, HA01218, HA01220, Expires: 10/31/2026; HA01236, HA01238, HA01240, HA01244, HA01246, HA01248, HA01261, HA01263, HA01265, HA01267, HA01278, HA01280, HA01282, HA01284, HA01288, HA01290, HA01292, HA01298, Expires: 11/30/2026; HB00002, HB00004, HB00006, HB00017, HB00019, HB00021, HB00023, HB00025, HB00031, HB00033, HB00035, HB00037, HB00039, HB00041, HB00043, Expires: 12/31/2026; HB00049, HB00051, HB00076, HB00078, HB00080, HB00082, HB00084, Expires: 1/31/2027; HB00128, HB00130, HB00132, HB00134, HB00157, HB00159, HB00161, HB00196, HB00198, HB00200, Expires: 2/28/2027; HB00224, HB00226, HB00228, HB00230, HB00240, HB00242, Expires: 3/31/2027; HB00416, HB00417, HB0041... [TRUNCATED] |
| Postal code | 34108-2734 |
| Report date | 20260708 |
| Product type | Drugs |
| Product quantity | 2,530,182 bottles |
| Reason for recall | Presence of Foreign Substance |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260604 |
| Initial firm notification | Letter |
| Center classification date | 20260630 |
Overview
- Recalling FirmLupin Pharmaceuticals Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionU.S. Nationwide