April 2018 FDA Recall Drug by Rhodes Pharmaceuticals, L.p.
D-0710-2018 - Failed Dissolution Specification
This Class III drug recall was voluntarily initiated by Rhodes Pharmaceuticals, L.p. on April 17, 2018 for the product Drug. The FDA reported the reason for recall as failed dissolution specification. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0710-2018
Failed Dissolution Specification: Low dissolution outside of specifications
04-17-2018
05-09-2018
2454 bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Rhodes Pharmaceuticals, L.P.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide within the USA
05-19-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# AG8679B Exp. 01/2020
