June 2014 FDA Recall Drug by Unit Dose Solutions Inc
D-0017-2015 - Presence of Foreign Tablets/Capsules
This Class II drug recall was voluntarily initiated by Unit Dose Solutions Inc on June 2, 2014 for the product Drug. The FDA reported the reason for recall as presence of foreign tablets/capsules. The product was distributed in PA and the recall is currently terminated.
Recall Number: D-0017-2015
Presence of Foreign Tablets/Capsules:179 doses of Valacyclovir HCl 500 mg tablets were repacked in unit dose packslabeled as Atorvastatin Calcium
06-02-2014
10-22-2014
1,177 packets
Recall Profile & Regulatory Data
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.
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.
Unit Dose Solutions Inc
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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
PA
10-16-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Atorvastatin Calcium 40 MG Tablet, MFG: Apotex NDC# 6050525808
Batch or Lot Expiration Information
Lot# Lot 204751 Exp. 04/15
