FDAFDA · Food and drugs·Recall number D-847-2013
Methylphenidate Hydrochloride Extended-Release Capsules (LA), 20 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5346-01
Published August 14, 2013 · Recall initiated: June 18, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Dissolution Specifications: Product is being recalled due to out of specification dissolution results obtained during routine stability testing.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- METHYLPHENIDATE HYDROCHLORIDE
- Manufacturer
- Teva Pharmaceuticals USA, Inc.
- Distributor
- Nationwide
- UPC
- 009353460134
- Lot
- 34010282A, 34010283A, 34010284A, 34010285A, 34010286A and 34010565A, exp 04/14; 34013199A, 34013200A, 34013201A, 34013202A and 34013203A, exp 10/14.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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