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FERROUS SULFATE ELIXIR 220 mg/5 mL, UPC 350838778059, NDC 50383-778-05 --- H...

FDA Recall #F-1380-2015 — Class II — December 23, 2014

Recall #F-1380-2015 Date: December 23, 2014 Classification: Class II Status: Terminated

Product Description

FERROUS SULFATE ELIXIR 220 mg/5 mL, UPC 350838778059, NDC 50383-778-05 --- HI-TECH PHARMACAL CO, INC. AMITYVILLE, NY 11701

Reason for Recall

Out-of-specification result for pH observed during stability testing of Ferrous Sulfate Elixir, 5 mL unit dose, Lot 621120.

Recalling Firm

Hi-Tech Pharmacal Co., Inc. — Amityville, NY

Classification

Class II — A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Product Type

Food

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop consuming this product immediately. Check your home for the recalled item and dispose of it safely. If you experienced a health issue after consuming this product, contact your doctor and report it to the FDA MedWatch.

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