Reported May 9, 2018 · Terminated
Aptensio XR (methylphenidate HCl extended-release) capsules 15 mg Rx Only 90-count bottle. Marketed by: Rhodes…
Rhodes Pharmaceuticals, LP
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Rhodes Pharmaceuticals, L.P. · 498 Washington St · Coventry, RI · 02816-5467
Is this the product you have?
- Aptensio XR (methylphenidate HCl extended-release) capsules 15 mg Rx Only 90-count bottle
- Marketed byRhodes Pharmaceuticals L.P., Coventry, RI 02816
- Manufactured byPatheon Manufacturing Services LLC, Greenville, NC 27834. NDC 42858-402-45
- Lot codes and dates
- Lot# AG8679B Exp. 01/2020
- Amount recalled
- 2454 bottles
Where it was sold
- Nationwide
Why it was recalled
Failed Dissolution Specification: Low dissolution outside of specifications
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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