Terminated Class II

Hi-Tech Pharmacal Co., Inc.

Recall F-1380-2015 · Amityville, NY

Product

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.

Distribution

NJ, OH, TX, LA, and Puerto Rico

Quantity affected

581 units

Recall type

Voluntary: Firm initiated

Lot / code info

Lot 62110, exp. date 04/2015

Timeline

23 Dec 2014 initiated → 3 Mar 2015 classified → 11 Mar 2015 reported → 8 May 2017 terminated

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