Methylphenidate Hydrochloride Capsule, Extended Release
FDA Recall NDC 0093-5347
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 Methylphenidate Hydrochloride (NDC 0093-5347). A significant event, classified as Class II, was initiated on Jun 18, 2013 by Teva Pharmaceuticals Usa, Inc.. The reported reason for this action was: "Failed Dissolution Specifications: Product is being recalled due to out of specification dissolution results obtained during routine stability testing."
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
Failed Dissolution Specifications: Product is being recalled due to out of specification dissolution results obtained during routine stability testing.
Jun 18, 2013
Aug 14, 2013
16,293 bottles
Recall Profile & Regulatory Data
Event ID
65515
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Teva Pharmaceuticals USA, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Aug 27, 2014
Product Description
Methylphenidate Hydrochloride Extended-Release Capsules (LA), 20 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5346-01
Batch or Lot Expiration Information
Lot# 34010282A, 34010283A, 34010284A, 34010285A, 34010286A and 34010565A, exp 04/14; 34013199A, 34013200A, 34013201A, 34013202A and 34013203A, exp 10/14.
Affected Packages Involved in this Recall
0093-5346-01Product
0093-5347-01Product
0093-5348-01Product
Class II Terminated
Failed Dissolution Specifications: Product is being recalled due to out of specification dissolution results obtained during routine stability testing.
Jun 18, 2013
Aug 14, 2013
7,579 bottles
Recall Profile & Regulatory Data
Event ID
65515
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Teva Pharmaceuticals USA, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Aug 27, 2014
Product Description
Methylphenidate Hydrochloride Extended-Release Capsules (LA), 40 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5348-01
Batch or Lot Expiration Information
Lot# 34010287A, 34010288A, 34010289A, exp 4/2014; 34011513A, 34011514A, and 34011515A, exp 06/14.
Affected Packages Involved in this Recall
0093-5346-01Product
0093-5347-01Product
0093-5348-01Product
Class II Terminated
Failed Dissolution Specifications: Product is being recalled due to out of specification dissolution results obtained during routine stability testing.
Jun 18, 2013
Aug 14, 2013
13,478 bottles
Recall Profile & Regulatory Data
Event ID
65515
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Teva Pharmaceuticals USA, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Aug 27, 2014
Product Description
Methylphenidate Hydrochloride Extended-Release Capsules (LA), 30 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5347-01
Batch or Lot Expiration Information
Lot# 34010290A, 34010291A, 34010292A, exp 04/14, 34011855A, 34011856A, 34011857A, 34011858A, 34013216A, 34013217A, 34013218A, exp 06/14.
Affected Packages Involved in this Recall
0093-5346-01Product
0093-5347-01Product
0093-5348-01Product
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.
