Food, drugs, devices › Allergan Sales, LLC
Drug recall: Blephamide (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10%/0.2% sterile, 3.5 g tube, RX onl
FDA enforcement event 77143 is a drug recall by Allergan Sales, LLC of Waco, TX, initiated 1 May 2017 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 57% of the 343 drug enforcement events initiated in 2017 carry the same class.
Status: Terminated, terminated 1 May 2019. Initiation: voluntary: firm initiated. Allergan Sales, LLC has 8 enforcement events on this register, with a median of 2 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Allergan Sales, LLC, Waco, TX.
Reason for recall
"Failed Impurities/Degradation Specifications: stability testing results did not meet the specification for impurities."
Distribution
"Nationwide in the US"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0929-2017 | 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. | 648 units | Class II | Terminated | 5 Jul 2017 |
Context
Other enforcement events for Allergan Sales, LLC
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 14 Mar 2024 | Keller Funnel 2, REF: HA-001, STERILEEO, Rx Only, | Device | Class II | 1 |
| 19 Mar 2019 | Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5% 5 mL bottles, Rx only, Allergan, Inc. Irvi | Drug | Class II | 1 |
| 19 Oct 2017 | Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5%, Rx only, packaged in a) 2.5 mL NDC# 0023- | Drug | Class III | 2 |
| 16 Mar 2017 | Lumigan (bimatoprost ophthalmic solution) 0.01%, 7.5 mL bottle, Rx only, Allergan Irvine, CA 92612, NDC 0023-3205-08. | Drug | Class III | 1 |
| 30 Jun 2016 | TAZORAC (tazarotene) Gel 0.05%, Rx only, For Dermatologic Use Only, Not for Ophthalmic Use, packaged in a) 30 g tubes (N | Drug | Class II | 2 |
| 10 May 2016 | Tazorac (tazarotene) Gel 0.05%, Rx only, packaged in a) 30g (NDC 0023-8335-03) and b) 100g (NDC 0023-8335-10) tubes, All | Drug | Class II | 2 |
| 24 Aug 2015 | Refresh Lacri-Lube (Mineral Oil 42.5% and White Petrolatum 56.8%) Lubricant Eye Ointment, packaged in a) Net wt. 0.12 oz | Drug | Class II | 4 |
All 8 events for Allergan Sales, LLC
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Failed Impurities/Degradation Specifications: stability testing results did not meet the specification for impurities."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide in the US"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 1 May 2019. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.