Isotretinoin Capsule, Liquid Filled
FDA Recall NDC 69238-1017
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 Isotretinoin (NDC 69238-1017). A significant event, classified as Class III, was initiated on Oct 16, 2019 by Amneal Pharmaceuticals Ny Llc. The reported reason for this action was: "Failed Impurities/Degradation Specifications: Tretinoin levels slightly above specification limits."
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
October 2019 Class III Recall: Failed Impurities/Degradation Specifications
Recall Number
Class III Terminated
Failed Impurities/Degradation Specifications: Tretinoin levels slightly above specification limits.
Oct 16, 2019
Nov 20, 2019
2460 cartons/3 blister cards/10 capsules each
Recall Profile & Regulatory Data
Event ID
84073
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Amneal Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Recalled product was distributed to retailers and wholesalers who may have further distribute the product.
Termination Date
Nov 09, 2020
Product Description
Isotretinoin Capsules, USP 10 mg. Rx Only, 3 Prescription Blister Packs of 10- Capsules Each (30 Capsules)-. Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC 69238-1174-3
Batch or Lot Expiration Information
Batch# Batch Numbers: BL10917, BL11017, BL11117, Exp. date 11/2019
Affected Packages Involved in this Recall
69238-1174-1Product
69238-1174-3Product
69238-1175-1Product
69238-1175-3Product
69238-1017-1Product
69238-1017-3Product
69238-1176-1Product
69238-1176-3Product
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.
