December 2021 FDA Recall Drug by Lohxa, Llc
D-0377-2022 - Microbial Contamination of Non-Sterile Product

This Class I drug recall was voluntarily initiated by Lohxa, Llc on December 21, 2021 for the product Drug. The FDA reported the reason for recall as microbial contamination of non-sterile product. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0377-2022

Reason for Recall
Microbial Contamination of Non-Sterile Product
Initiated
12-21-2021
Reported
01-26-2022
Quantity
87,840 unit dose cups

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89272
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.
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.
Product was distributed to one wholesale who further distributed the product nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-15-2022
Product Description About Product Description
Full technical description of the product.
SENNA Syrup (sennosides) 8.8 mg/ 5 mL unit-dose cups, packaged in 24 cups per carton, Mfg for: AvKARE, TN 38478, NDC 50262-731-24.

Batch or Lot Expiration Information

Lot# : AM1115S, Exp. Date 01/2023