October 2014 FDA Recall Methylprednisolone by American Health Packaging
D-0043-2015 - Subpotent; 6 month stability time point

This Class III drug recall was voluntarily initiated by American Health Packaging on October 10, 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-0043-2015

Reason for Recall
Subpotent; 6 month stability time point
Initiated
10-10-2014
Reported
10-29-2014
Quantity
2,005 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
69511
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
American Health Packaging
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-01-2015
Product Description About Product Description
Full technical description of the product.
MethylPREDNISolone Tablets, USP, 4 mg, 100 unit dose blisters, Packaged and Distributed by: American Health Packaging, Columbus, OH ---- Carton of 100 NDC 68084-149-01, Individual Dose NDC 68084-149-11

Batch or Lot Expiration Information

Lot# AHP
Lot# : 134124 and 140364 Expiration Date of both lots: 05/2015 Carton NDC #: 68084-149-01 Single Dose NDC #: 68084-149-11

Affected Packages Involved in this Recall

68084-149-11 Methylprednisolone
68084-149-01 Methylprednisolone