June 2015 FDA Recall Drug by The Harvard Drug Group, Llc
D-1150-2015 - Superpotent Drug

This Class II drug recall was voluntarily initiated by The Harvard Drug Group, Llc on June 10, 2015 for the product Drug. The FDA reported the reason for recall as superpotent drug. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1150-2015

Reason for Recall
Superpotent Drug: Confirmed customer complaint of a single unit dose blister cavity containing 2 OXYCODONE HCl 5 mg tablets.
Initiated
06-10-2015
Reported
07-08-2015
Quantity
12,717 tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71454
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Harvard Drug Group, LLC
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.
09-12-2016
Product Description About Product Description
Full technical description of the product.
OXYCODONE HCl C-II Tablets, 5 mg USP, 100-count blister cards, Rx only, Manufactured by Nesher Pharmaceuticals USA LLC., St. Louis, MO 63044, Distributed by Major Pharmaceuticals, Livonia, MI 48150, NDC 0904-6444-61.

Batch or Lot Expiration Information

Lot# P-20000; Exp. 08/16
Lot# P-20004; Exp. 08/16