Class III · Low risk
Fabior (tazarotene)
Superpotent Drug: High out of specification results for tazarotene assay at the 9-month stability time point.
TAZORAC (tazarotene)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Content Uniformity Specifications
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
What was recalled
TAZORAC (tazarotene) Gel 0.05%, Rx only, For Dermatologic Use Only, Not for Ophthalmic Use, packaged in a) 30 g tubes (NDC: 0023-8335-03, UPC: 300238335036) and b)100 g tubes,(NDC: 0023-8335-10, UPC: 300238335104), Manufactured by: Allergan Inc., Irvine, CA 92512.
Affected NDCs
0023-8335-03
0023-8335-10
Compare with the code on your package — it is the most precise check available.
Drug: Tazarotene Category: Eye Drops & Ophthalmic
- Recalling firm
- Allergan Sales, LLC
- Origin
- TX, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0099-2017 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Tazarotene recalls
See all
Class II · Moderate risk
TAZORAC (tazarotene)
Failed Content Uniformity Specifications
Class II · Moderate risk
Tazorac (tazarotene)
Failed Content Uniformity Specifications.
Class II · Moderate risk
Tazorac (tazarotene)
Failed Content Uniformity Specifications.
Other recalls by Allergan Sales, LLC
All 2016 recalls
Class II · Moderate risk
Class III · Low risk
Lumigan (bimatoprost ophthalmic solution)
Failed Impurities/Degradation Specifications.
Class III · Low risk
Combigan (brimonidine tartrate/timolol maleate ophthalmic solution)
Failed Impurities/Degradation Specifications.
Class II · Moderate risk
Blephamide
Failed Impurities/Degradation Specifications: stability testing results did not meet the specification for impurities.
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