FDA Drug recall D-0929-2017
Blephamide (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10%/0.2% sterile, 3.5 g tube, RX only, Manufactured by…
- FDA Drug
- Class II
- terminated
- Published 2017-07-05
On 2017-07-05 the FDA classified a Class II recall of Blephamide (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10%/0.2% sterile, 3.5 g tube, RX only, Manufactured by… by Allergan Sales, citing failed Impurities/Degradation Specifications: stability testing results did not meet the specification for impurities.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0929-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-05-01 |
| Published | 2017-07-05 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Allergan Sales |
| Distribution | US |
Product
Blephamide (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10%/0.2% sterile, 3.5 g tube, RX only, Manufactured by Allergan, Irvine, California, 92612, U.S.A., NDC: 0023-0313-04.
Reason
Failed Impurities/Degradation Specifications: stability testing results did not meet the specification for impurities.
Identifiers
| code_info | Lot: 93802, EXP NOV 2019 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Other recalls by Allergan Sales
- Keller Funnel 2, REF: HA-001, STERILEEO, Rx Only
FDA Device · Class II · 2024-05-08 · Allergan Sales - Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5% 5 mL bottles, Rx only, Allergan, Inc
FDA Drug · Class II · 2019-04-03 · Allergan Sales - Lumigan (bimatoprost ophthalmic solution) 0.01%, 2.5 mL bottle, Rx only, Allergan, Irvine, CA 92612
FDA Drug · Class III · 2017-11-22 · Allergan Sales - Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5%, Rx only, packaged in a) 2.5 mL NDC# 0023-9211-03
FDA Drug · Class III · 2017-11-22 · Allergan Sales - Lumigan (bimatoprost ophthalmic solution) 0.01%, 7.5 mL bottle, Rx only, Allergan Irvine, CA 92612, NDC 0023-3205-08
FDA Drug · Class III · 2017-04-19 · Allergan Sales
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0929-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.