Methylphenidate Hydrochloride Tablet, Film Coated, Extended Release
FDA Recall NDC 62037-727
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Methylphenidate Hydrochloride (NDC 62037-727). A significant event, classified as Class II, was initiated on Jan 27, 2020 by Actavis Pharma, Inc.. The reported reason for this action was: "CGMP deviations: Product bottle may be absent of desiccant."
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
CGMP deviations: Product bottle may be absent of desiccant.
Jan 27, 2020
Feb 19, 2020
17,436 bottles
Recall Profile & Regulatory Data
Event ID
84797
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Teva Pharmaceuticals USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide
Termination Date
Nov 03, 2020
Product Description
Methylphenidate hydrochloride Extended-Release ablets USP (CII), 27 mg, 100-count bottle, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 62037-734-01
Batch or Lot Expiration Information
Lot# 1332799A, Exp 11/2020
Affected Packages Involved in this Recall
62037-725-01Product
62037-734-01Product
62037-726-01Product
62037-727-01Product
Class II Terminated
CGMP deviations: Product bottle may be absent of desiccant.
Jan 27, 2020
Feb 19, 2020
N/A
Recall Profile & Regulatory Data
Event ID
84797
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Teva Pharmaceuticals USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide
Termination Date
Nov 03, 2020
Product Description
Methylphenidate hydrochloride Extended-Release ablets USP (CII), 18 mg, 100-count bottle, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 62037-725-01
Batch or Lot Expiration Information
Lot# : 1332796 A, Exp 11/2020
Affected Packages Involved in this Recall
62037-725-01Product
62037-734-01Product
62037-726-01Product
62037-727-01Product
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.
