May 2016 FDA Recall Drug by Virtus Pharmaceuticals, Llc
D-1044-2016 - Chemical Contamination

This Class III drug recall was voluntarily initiated by Virtus Pharmaceuticals, Llc on May 13, 2016 for the product Drug. The FDA reported the reason for recall as chemical contamination. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1044-2016

Reason for Recall
Chemical Contamination: Bottles may contain broken dessicants
Initiated
05-13-2016
Reported
06-29-2016
Quantity
24,614 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74251
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.
Virtus Pharmaceuticals, 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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide & Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-21-2018
Product Description About Product Description
Full technical description of the product.
Hyoscyamine Sulfate Sublingual Tablets, 0.125 mg, packaged in 100-count bottles, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC. Nashville, TN 37217. NDC 76439-0309-10

Batch or Lot Expiration Information

Lot# : 638J011A