February 2018 FDA Recall Acyclovir by Apace Ky Llc
D-0544-2018 - Presence of Foreign Tablet/Capsule; cartons labeled to contain Acyclovir tablets may contain Torsemide tablets in some of the blister cavities.

This Class II drug recall was voluntarily initiated by Apace Ky Llc on February 9, 2018 for the product Acyclovir. The FDA reported the reason for recall as presence of foreign tablet/capsule; cartons labeled to contain acyclovir tablets may contain torsemide tablets in some of the blister cavities.. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0544-2018

Reason for Recall
Presence of Foreign Tablet/Capsule; cartons labeled to contain Acyclovir tablets may contain Torsemide tablets in some of the blister cavities.
Initiated
02-09-2018
Reported
03-07-2018
Quantity
630 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79194
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.
Apace KY 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.
09-10-2019
Product Description About Product Description
Full technical description of the product.
Acyclovir Tablets, USP, 400 mg, 50 Tablets (5 x 10) unit dose blisters [NDC 50268-061-11] per carton [NDC 50268-061-15], Rx Only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478

Batch or Lot Expiration Information

Lot# Lot: 19900, exp 05/2019

Affected Packages Involved in this Recall

50268-061-11 Acyclovir
50268-061-15 Acyclovir
50268-062-11 Acyclovir
50268-062-15 Acyclovir