FDAFDA · Food and drugs·Recall number D-849-2013
Methylphenidate Hydrochloride Extended-Release Capsules (LA), 40 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5348-01
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
- Lot
- 34010287A, 34010288A, 34010289A, exp 4/2014; 34011513A, 34011514A, and 34011515A, exp 06/14.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.