CLASS II Drug recall · Reported 5 Jul 2017 · FDA Enforcement Report
Blephamide (sulfacetamide sodium recalled by Allergan Sales
Allergan Sales is recalling Blephamide (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP), distributed nationwide in the US. The recall was initiated on 1 May 2017 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0929-2017
- FDA event ID
- 77143
- Recalling firm
- Allergan Sales, Waco, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 May 2017
- FDA classified
- 29 Jun 2017
- Reported
- 5 Jul 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Eye Drops
Timeline
| 1 May 2017 | Recall initiated by company | |
| 29 Jun 2017 | Classified by FDA | +59 days |
| 5 Jul 2017 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications: stability testing results did not meet the specification for impurities.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the US
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications: stability testing results did not meet the specification for impurities.
Which lots are affected?
Lot: 93802, EXP NOV 2019
Where was it sold?
Nationwide in the US
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Allergan Sales
All 14| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Keller Funnel recalled by Allergan Sales | Allergan Sales | Other | Nationwide |
| Drug | CLASS II | Combigan (brimonidine tartrate/timolol maleate ophthalmic recalledCombigan | Allergan Sales | Manufacturing (CGMP) Deviations | TN |
| Drug | CLASS III | Lumigan (bimatoprost ophthalmic solution) recalled by Allergan SalesLumigan | Allergan Sales | Potency & Assay | Nationwide |
| Drug | CLASS III | Combigan (brimonidine tartrate/timolol maleate ophthalmic recalledCombigan | Allergan Sales | Potency & Assay | Nationwide |
| Drug | CLASS III | Lumigan (bimatoprost ophthalmic solution) recalled by Allergan SalesLumigan | Allergan Sales | Potency & Assay | Nationwide |
Other Blephamide (sulfacetamide recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Blephamide (sulfacetamide sodium recalled by Allergan Sales | Allergan Sales | Particulate Matter | Nationwide |