Lillow (Levonorgestrel and Ethinyl Estradiol Tablets, USP), 0.15 mg/0.03 mg, 1 Blister Pack Conta...

FDA Recall #D-0187-2024 — Class II — January 26, 2022

Recall #D-0187-2024 Date: January 26, 2022 Classification: Class II Status: Terminated

Product Description

Lillow (Levonorgestrel and Ethinyl Estradiol Tablets, USP), 0.15 mg/0.03 mg, 1 Blister Pack Containing 28 Tablets, Rx only, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC 69238-1554-6

Reason for Recall

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

Recalling Firm

CARDINAL HEALTHCARE — Dublin, OH

Classification

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

Product Type

Drugs

Product Quantity

1 unit

Distribution

Nationwide USA

Code Information

Batch A5921

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated