Food recall

Hi-Tech Pharmacal Co., Inc. recall: FERROUS SULFATE ELIXIR 220 mg/5 mL

Hi-Tech Pharmacal Co., Inc., of Amityville, NY, recalled FERROUS SULFATE ELIXIR 220 mg/5 mL. The FDA's reason: “Out-of-specification result for pH observed during stability testing of Ferrous Sulfate Elixir, 5 mL unit dose, Lot 621120.” The FDA classified it Class II: it could cause temporary or minor harm. The company began the recall voluntarily on December 23, 2014, and the FDA first listed it in its Enforcement Report of March 11, 2015. The FDA has closed the recall: it found the company did all it reasonably could to remove or correct the product.

How serious

Class II

It could cause temporary or minor harm

Why

Other germs or toxins (botulism, hepatitis A, mold...)

Status

Terminated

Closed May 8, 2017

The recall

Company
Hi-Tech Pharmacal Co., Inc. (Amityville, NY)
Reason, in FDA's words
“Out-of-specification result for pH observed during stability testing of Ferrous Sulfate Elixir, 5 mL unit dose, Lot 621120.”
Where it was sold
NJ, OH, TX, LA, and Puerto Rico
Recall began
, by the company
FDA classified it
First in an FDA Enforcement Report
FDA event number
70097

The product recalled

As the FDA describes them, with the codes that tell whether a package is part of the recall.

  • F-1380-2015 Class II

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

    Codes: Lot 62110, exp. date 04/2015

    Quantity: 581 units

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Source and notes

U.S. Food and Drug Administration, Enforcement Reports (openFDA food recall data) (Public domain (U.S. government work); source U.S. Food and Drug Administration, openFDA), data as of March 11, 2015.

Each week the FDA lists the recalls it has classified in its Enforcement Report, often weeks after the company announced the recall, so a month with five weekly reports tends to count more. Each recall counts once, however many products it covers, in the month FDA first listed it. Class I means the food could cause serious harm or death, Class II temporary or minor harm, and Class III is unlikely to harm anyone. Meat, poultry and most egg products are recalled by the U.S. Department of Agriculture, not the FDA, and aren't included. For what to do with a recalled product, see the FDA's recalls page.