Multi-event March 2022 FDA Recall Drug by Direct Rx

This Multi-event Class II drug recall was voluntarily initiated by Direct Rx on March 4, 2022 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in FL, GA, LA and the recall is currently terminated.

Reported Recall Events

D-0651-2022 TERMINATED D-0650-2022 TERMINATED

Recall Number: D-0651-2022

Reason for Recall
CGMP Deviations: The Recall is due to the potential cross-contamination at the contract manufacturer (Ultra Tab Laboratories Inc.)
Initiated
03-04-2022
Reported
03-16-2022
Quantity
8 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89749
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.
Direct Rx
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.
FL, GA, LA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-02-2022
Product Description About Product Description
Full technical description of the product.
Alprazolam C-IV 2 mg, 60-count bottles, Rx Only, Dist. By: Par Pharmaceutical Chestnut Ridge, NY 10977 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC 72189-0058-60

Batch or Lot Expiration Information

Lot# : 07NO1901 Exp. 5/31/22

Recall Number: D-0650-2022

Reason for Recall
CGMP Deviations: The Recall is due to the potential cross-contamination at the contract manufacturer (Ultra Tab Laboratories Inc.)
Initiated
03-04-2022
Reported
03-16-2022
Quantity
16 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89749
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.
Direct Rx
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.
FL, GA, LA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-02-2022
Product Description About Product Description
Full technical description of the product.
Alprazolam C-IV 1 mg 60-count bottles, Rx Only, Dist. By: Par Pharmaceutical Chestnut Ridge, NY 10977 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC 61919-836-60

Batch or Lot Expiration Information

Lot# : 19AU1910 Exp. 5/31/22