D-0099-2017 Class II Terminated
FDA drug recall D-0099-2017 was initiated by Allergan Sales, LLC on Jun 30, 2016 and is designated Class II. Reason for recall: Failed Content Uniformity Specifications The recall status is terminated (terminated Dec 6, 2017). Affected quantity: 25,247 tubes (19,499 30 gram/ 5,748 100 gram).
Recall details
- Product Type
- Drugs
- Report Date
- Oct 19, 2016
- Initiation Date
- Jun 30, 2016
- Termination Date
- Dec 6, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 25,247 tubes (19,499 30 gram/ 5,748 100 gram)
Product description
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.
Reason for recall
Failed Content Uniformity Specifications
Distribution pattern
Nationwide
Code information
a) Lot# 82579; Exp. 10/16 b) Lot:# 85088 Exp. 05/17
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0099-2017
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026