Reported Mar 11, 2015 · Terminated

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

Hi-Tech Pharmacal Co., Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Hi-Tech Pharmacal Co., Inc. · 369 Bayview Ave · Amityville, NY · 11701-2801

Is this the product you have?

    • FERROUS SULFATE ELIXIR 220 mg/5 mL
    • UPC 350838778059
    • NDC 50383-778-05 --- HI-TECH PHARMACAL CO
    • INC. AMITYVILLE
    • NY 11701
Lot codes and dates
    • Lot 62110
    • exp. date 04/2015
Amount recalled
581 units

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA food enforcement) notice

Notice updated May 8, 2017 · Data as of Sep 19, 4:59 PM UTC

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