MYLICON INFANT GAS DROPS 0.5 OZ distributed to specific Family Dollar Stores 04/30/2022 through 0...

FDA Recall #D-1442-2022 — Class II — June 23, 2022

Recall #D-1442-2022 Date: June 23, 2022 Classification: Class II Status: Ongoing

Product Description

MYLICON INFANT GAS DROPS 0.5 OZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.

Reason for Recall

CGMP Deviations: product held outside appropriate storage temperature conditions.

Recalling Firm

Family Dollar Stores, Llc. — Chesapeake, VA

Classification

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

Product Type

Drugs

Product Quantity

Unknown

Distribution

Nationwide within the United States

Code Information

SKU:999109

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated