SENNA Syrup (sennosides) 8.8 mg/ 5 mL unit-dose cups, packaged in 24 cups per carton, Mfg for: Av...

FDA Recall #D-0377-2022 — Class I — December 21, 2021

Recall #D-0377-2022 Date: December 21, 2021 Classification: Class I Status: Terminated

Product Description

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.

Reason for Recall

Microbial Contamination of Non-Sterile Product

Recalling Firm

Lohxa, LLC — Worcester, MA

Classification

Class I — Reasonable probability of serious adverse health consequences or death.

Product Type

Drugs

Product Quantity

87,840 unit dose cups

Distribution

Product was distributed to one wholesale who further distributed the product nationwide in the USA

Code Information

Lot #: AM1115S, Exp. Date 01/2023

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated