GOOD SENSE OMEPRAZOLE TABLET 14CT SKU 900055 PRILOSEC OTC TABLET 14 CT SKU914128 distributed t...

FDA Recall #D-1417-2022 — Class II — June 23, 2022

Recall #D-1417-2022 Date: June 23, 2022 Classification: Class II Status: Ongoing

Product Description

GOOD SENSE OMEPRAZOLE TABLET 14CT SKU 900055 PRILOSEC OTC TABLET 14 CT SKU914128 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

SKUs: 900055; 914128

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated