Drug Enforcement D-848-2013

Failed Dissolution Specifications: Product is being recalled due to out of specification dissolution results obtained during routine stability testing.

Status

Terminated

Classification

Class II

Report Date

August 14, 2013

Termination Date

August 27, 2014

Product Information

Product description
Methylphenidate Hydrochloride Extended-Release Capsules (LA), 30 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5347-01
Product quantity
13,478 bottles
Reason for recall
Failed Dissolution Specifications: Product is being recalled due to out of specification dissolution results obtained during routine stability testing.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide

Location & Firm

Recalling firm
Teva Pharmaceuticals USA, Inc.
Address
650 Cathill Rd, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-848-2013
Event ID
65515
Recall initiation date
June 18, 2013
Center classification date
August 7, 2013
Code info
34010290A, 34010291A, 34010292A, exp 04/14, 34011855A, 34011856A, 34011857A, 34011858A, 34013216A, 34013217A, 34013218A, exp 06/14.
More code info
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