Babelyn Diarrhea Drops Homeopathic Remedy, 0.5 fl. oz. (15 mL) bottles, Distributed by Pharmadel ...

FDA Recall #D-0883-2023 — Class II — June 5, 2023

Recall #D-0883-2023 Date: June 5, 2023 Classification: Class II Status: Terminated

Product Description

Babelyn Diarrhea Drops Homeopathic Remedy, 0.5 fl. oz. (15 mL) bottles, Distributed by Pharmadel LLC, Georgetown, DE NDC 55758-035-01

Reason for Recall

cGMP deviations

Recalling Firm

Homeocare Laboratories, Inc. — Yonkers, NY

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

5957 bottles

Distribution

Product was distributed USA nationwide.

Code Information

Lot # 2413, exp. date Sep-24

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated