Fluocinolone Acetonide Oil
FDA Recall NDC 64980-331
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Fluocinolone Acetonide (NDC 64980-331). A significant event, classified as Class II, was initiated on Apr 13, 2018 by Rising Pharma Holdings, Inc.. The reported reason for this action was: "Subpotent Drug"
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
Class II Terminated
Subpotent Drug
Apr 13, 2018
May 02, 2018
12572 units
Recall Profile & Regulatory Data
Event ID
79860
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Lyne Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
to be entered
Termination Date
May 16, 2019
Product Description
Fluocinolone Acetonide Topical Oil, 0.01% (Body Oil) 118.28 mL (4 fl. oz.) Rx Only, Manufactured by: Lyne Laboratories, Inc. Brockton, MA 02307 Manufactured for: Rising Pharmaceuticals, Inc. Allendale, NJ 07401, NDC 64980-331-04, UPC 364980331043
Batch or Lot Expiration Information
Lot# : FR1603, FR1604A, Exp. 05/2018
Affected Packages Involved in this Recall
64980-331-04Product
3649803310Product
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.
