D-0909-2018 Class II Terminated
FDA drug recall D-0909-2018 was initiated by Teva Pharmaceuticals USA on Jul 5, 2018 and is designated Class II. Reason for recall: Failed Impurities and Degradation Specifications and Subpotent Drug: out-of-specification (OOS) test results for below assay and above specification for degradants. The recall status is terminated (terminated Apr 3, 2019). Affected quantity: 27,803 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Jul 18, 2018
- Initiation Date
- Jul 5, 2018
- Termination Date
- Apr 3, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 27,803 bottles
Product Description
Fluocinolone Acetonide Topical Solution, USP, 0.01%, 60 mL bottle, Rx Only, Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, UT 84108 USA; Distributed by: Actavis Pharmac, Inc., Parsippany, NJ 07054 USA, NDC 0591-2990-60.
Reason for Recall
Failed Impurities and Degradation Specifications and Subpotent Drug: out-of-specification (OOS) test results for below assay and above specification for degradants.
Distribution Pattern
Nationwide in the USA and Puerto Rico
Code Information
Lot #s: 1164898, EXP 10/18; 1164904, 1164909, EXP 11/18; 1211396, EXP 07/19; 1230808, 1231127, EXP 01/20
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0909-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026