Home / Hi-Tech Pharmacal Co., Inc. / F-1380-2015
Class II
Hi-Tech Pharmacal Co., Inc.
Recall #F-1380-2015 · Initiated 2014-12-23
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.
Quantity affected
581 units
Distribution
NJ, OH, TX, LA, and Puerto Rico
Lot / code info
Lot 62110, exp. date 04/2015
Voluntary / mandated
Voluntary: Firm initiated
Initial notification
Letter
Terminated
2017-05-08
Recalling firm
Hi-Tech Pharmacal Co., Inc.
369 Bayview Ave
Amityville, NY 11701-2801
United States
Recall classification
Remote probability of serious adverse health consequences, or temporary reversible consequences.