Multi-event March 2019 FDA Recall Drug by Lohxa Llc

This Multi-event Class II drug recall was voluntarily initiated by Lohxa Llc on March 25, 2019 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed in MA, NY and WY and the recall is currently terminated.

Reported Recall Events

D-1130-2019 TERMINATED D-1131-2019 TERMINATED

Recall Number: D-1130-2019

Reason for Recall
Labeling: Incorrect or Missing Lot and/or Exp Date - the label contains an incorrect Exp Date.
Initiated
03-25-2019
Reported
04-17-2019
Quantity
5 boxes - 250 unit dose cups.

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82538
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.
Lohxa 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.
MA, NY and WY
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-20-2023
Product Description About Product Description
Full technical description of the product.
Bismuth Subsalicylate Oral Suspension 262mg/15mL, unit dose cups, OTC, Rpkg. By.: Lohxa Worcester, MA, NDC 70166-059-01

Batch or Lot Expiration Information

Lot# : M030042P, Exp. 01/2020

Recall Number: D-1131-2019

Reason for Recall
Labeling: Incorrect or Missing Lot and/or Exp Date - the label contains an incorrect Exp Date.
Initiated
03-25-2019
Reported
04-17-2019
Quantity
46 boxes - 1380 unit dose cups

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82538
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.
Lohxa 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.
MA, NY and WY
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-20-2023
Product Description About Product Description
Full technical description of the product.
Phenobarbital Oral Solution, USP 20 mg/5mL, unit dose cup, Rx Only, Rpkg. By.Lohxa Worcester, MA 01608 NDC 70166-536-02

Batch or Lot Expiration Information

Lot# M12031, Exp. 12/2019; T01241 Exp. 02/2020