Recalls / Class II
Class IID-847-2013
Product
Methylphenidate Hydrochloride Extended-Release Capsules (LA), 20 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5346-01
- Brand name
- Methylphenidate Hydrochloride
- Generic name
- Methylphenidate Hydrochloride
- Active ingredient
- Methylphenidate Hydrochloride
- Route
- Oral
- NDCs
- 0093-5346, 0093-5347, 0093-5348
- FDA application
- ANDA079031
- Affected lot / code info
- 34010282A, 34010283A, 34010284A, 34010285A, 34010286A and 34010565A, exp 04/14; 34013199A, 34013200A, 34013201A, 34013202A and 34013203A, exp 10/14.
Why it was recalled
Failed Dissolution Specifications: Product is being recalled due to out of specification dissolution results obtained during routine stability testing.
Recalling firm
- Firm
- Teva Pharmaceuticals USA, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 650 Cathill Rd, N/A, Sellersville, Pennsylvania 18960-1512
Distribution
- Quantity
- 16,293 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-06-18
- FDA classified
- 2013-08-07
- Posted by FDA
- 2013-08-14
- Terminated
- 2014-08-27
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-847-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.