Multi-event September 2016 FDA Recall Drug by Virtus Pharmaceuticals Opco Ii L

This Multi-event Class I drug recall was voluntarily initiated by Virtus Pharmaceuticals Opco Ii L on September 2, 2016 for the product Drug. The FDA reported the reason for recall as failed content uniformity specifications. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0214-2017 TERMINATED D-0213-2017 TERMINATED D-0212-2017 TERMINATED

Recall Number: D-0214-2017

Reason for Recall
Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.
Initiated
09-02-2016
Reported
12-28-2016
Quantity
24,444 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75146
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
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 OPCO II L
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 and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-23-2019
Product Description About Product Description
Full technical description of the product.
Hyoscyamine Sulfate, USP Tablets, 0.125 mg, 100-count tablets per bottle, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC., Nashville, TN 37217, NDC 76439-308-10.

Batch or Lot Expiration Information

Lot# : 30031601, 30031602, Exp 01/18

Recall Number: D-0213-2017

Reason for Recall
Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.
Initiated
09-02-2016
Reported
12-28-2016
Quantity
10,572 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75146
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
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 OPCO II L
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 and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-23-2019
Product Description About Product Description
Full technical description of the product.
Hyoscyamine Sulfate, Orally Disintegrating Tablets, 0.125 mg, 100-count bottles, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC., Nashville, TN 37217, NDC 76439-307-10.

Batch or Lot Expiration Information

Lot# : 30011601, Exp 01/18

Recall Number: D-0212-2017

Reason for Recall
Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.
Initiated
09-02-2016
Reported
12-28-2016
Quantity
94,643 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75146
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
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 OPCO II L
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 and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-23-2019
Product Description About Product Description
Full technical description of the product.
Hyoscyamine Sulfate, Sublingual Tablets, 0.125 mg, 100-count bottle, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC., Nashville, TN 37217, NDC 76439-309-10.

Batch or Lot Expiration Information

Lot# : 30051601, 30051602*, 30051603, 30051604, Exp Jan-18, *some bottles contain the incorrect expiration date of Jan-28.