September 2014 FDA Recall Methylprednisolone by Qualitest Pharmaceuticals
D-1605-2014 - Subpotent; 6 month stability time point
This Class III drug recall was voluntarily initiated by Qualitest Pharmaceuticals on September 11, 2014 for the product Methylprednisolone. The FDA reported the reason for recall as subpotent; 6 month stability time point. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1605-2014
Subpotent; 6 month stability time point
09-11-2014
10-01-2014
159,913 tablets
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.
Qualitest Pharmaceuticals
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
01-27-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
MethylPREDNISolone TABLETS, USP 4 mg, a) 100 count bottles (NDC 0603-4593-21) and b) 21 count blister pack (NDC 0603-4593-15), Rx only, Mfg for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811
Batch or Lot Expiration Information
Lot# 100 count: T147F13A, Exp. 05/2015; 21 count: S003M14, Exp. 05/2015
