FDA Drug recall D-0092-2019
Fluocinolone Acetonide Topical Solution, USP 0.01%, 60ml Bottle, Manufactured for: Lupin Pharmaceutical, Inc
- FDA Drug
- Class II
- terminated
- Published 2018-10-31
On 2018-10-31 the FDA classified a Class II recall of Fluocinolone Acetonide Topical Solution, USP 0.01%, 60ml Bottle, Manufactured for: Lupin Pharmaceutical, Inc by Lupin Somerset, citing failed Impurities/Degradation Specifications:Out of specification result noticed for total impurities observed during stability analysis.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0092-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-10-05 |
| Published | 2018-10-31 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Lupin Somerset |
| Distribution | US |
Product
Fluocinolone Acetonide Topical Solution, USP 0.01%, 60ml Bottle, Manufactured for: Lupin Pharmaceutical, Inc. Baltimore, MD 21202 Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873. NDC 43386-069-60
Reason
Failed Impurities/Degradation Specifications:Out of specification result noticed for total impurities observed during stability analysis
Identifiers
| ndc | 43386-069-60 |
|---|---|
| code_info | Lot# M16666, EXP 12/2018 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0092-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.