Recalls / Class III
Class IIID-0710-2018
Product
Aptensio XR (methylphenidate HCl extended-release) capsules 15 mg Rx Only 90-count bottle. Marketed by: Rhodes Pharmaceuticals L.P., Coventry, RI 02816. Manufactured by: Patheon Manufacturing Services LLC, Greenville, NC 27834. NDC 42858-402-45
- Brand name
- Aptensio Xr
- Generic name
- Methylphenidate Hydrochloride
- Active ingredient
- Methylphenidate Hydrochloride
- Route
- Oral
- NDCs
- 42858-401, 42858-402, 42858-403, 42858-404, 42858-405, 42858-406, 42858-407
- FDA application
- NDA205831
- Affected lot / code info
- Lot# AG8679B Exp. 01/2020
Why it was recalled
Failed Dissolution Specification: Low dissolution outside of specifications
Recalling firm
- Firm
- Rhodes Pharmaceuticals, L.P.
- Manufacturer
- Rhodes Pharmaceuticals L.P.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 498 Washington St, N/A, Coventry, Rhode Island 02816-5467
Distribution
- Quantity
- 2454 bottles
- Distribution pattern
- Nationwide within the USA
Timeline
- Recall initiated
- 2018-04-17
- FDA classified
- 2018-05-03
- Posted by FDA
- 2018-05-09
- Terminated
- 2020-05-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0710-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.