MODERATE RISK
Terminated
F-1380-2015
FERROUS SULFATE ELIXIR 220 mg/5 mL, UPC 350838778059, NDC 50383-778-05 --- HI-TECH PHARMACAL CO, INC. AMITYVILLE, NY 11701
Recalled by Hi-Tech Pharmacal Co., Inc.
Classification
Class II — Products that might cause a temporary health problem, or pose only a slight threat of a serious nature.
Reason for Recall
Out-of-specification result for pH observed during stability testing of Ferrous Sulfate Elixir, 5 mL unit dose, Lot 621120.
Product Details
Product Quantity
581 units
Product Type
Food
Code Info
Lot 62110, exp. date 04/2015
Voluntary/Mandated
Voluntary: Firm initiated
Distribution & Geography
Distribution Pattern
NJ, OH, TX, LA, and Puerto Rico
Company Location
Amityville, NY, 11701-2801
Timeline
Report Date
03/11/2015
Recall Initiated
12/23/2014
Classification Date
03/03/2015
Termination Date
05/08/2017
Source: U.S. Food & Drug Administration (FDA) — FDA Recalls
Last updated: August 29, 2026
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