Fluocinolone Acetonide Solution
FDA Recall NDC 43386-069
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 3 recorded enforcement report(s) associated with Fluocinolone Acetonide (NDC 43386-069). A significant event, classified as Class II, was initiated on Jan 15, 2019 by Lupin Pharmaceuticals,inc.. The reported reason for this action was: "Failed Impurities/Degradation Specifications: Expansion of October 2018 recall due to elevated out of specification results for total impurities that have been chemically identified as oxidative degradation products of the fluocinolone active pharmaceutical ingredient."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
January 2019 Class II Recall: Failed Impurities/Degradation Specifications
Recall Number
Class II Terminated
Failed Impurities/Degradation Specifications: Expansion of October 2018 recall due to elevated out of specification results for total impurities that have been chemically identified as oxidative degradation products of the fluocinolone active pharmaceutical ingredient.
Jan 15, 2019
Jan 30, 2019
24,180 bottles
Recall Profile & Regulatory Data
Event ID
81925
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
LUPIN SOMERSET
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA and Puerto Rico
Termination Date
Feb 17, 2023
Product Description
Fluocinolone Acetonide Topical Solution, USP, 0.01 %, 60 mL bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202; Manufactured by: Novel Laboratories, Inc., Somerset, NJ 08873; NDC 43386-069-60.
Batch or Lot Expiration Information
Lot# : S700214, Exp Apr-19; S700447, Exp Jun-19; S700787, Exp Oct-19; S701057, Exp Nov-19; S800107, Exp Feb-20; S800266, Exp Mar-20; S800524, Exp May-20; S800791, Exp Jul-20
Affected Packages Involved in this Recall
43386-069-60Product
October 2018 Class II Recall: Failed Impurities/Degradation Specifications
Recall Number
Class II Terminated
Failed Impurities/Degradation Specifications:Out of specification result noticed for total impurities observed during stability analysis
Oct 05, 2018
Oct 31, 2018
2712 60-ml bottles
Recall Profile & Regulatory Data
Event ID
81168
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
LUPIN SOMERSET
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Nov 08, 2022
Product Description
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
Batch or Lot Expiration Information
Lot# M16666, EXP 12/2018
Affected Packages Involved in this Recall
43386-069-60Product
Class III Terminated
Chemical Contamination
Feb 22, 2017
Apr 19, 2017
7,656 bottles
Recall Profile & Regulatory Data
Event ID
76231
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Novel Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Aug 19, 2019
Product Description
Fluocinolone Acetonide Topical Solution USP 0.01% For Topical Use Only, Not for Ophthalmic Use, 60 mL bottle, Rx Only, Manufactured for Gavis Pharmaceuticals, LLC, Somerset NJ 08873, Manufactured by Novel Laboratories, Inc. Somerset, NJ 08873, NDC 43386-069-60
Batch or Lot Expiration Information
Lot# M15496; Exp. 10/17
Lot# M15507; Exp. 12/17
Affected Packages Involved in this Recall
43386-069-60Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
