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Hi-Tech Pharmacal Co., Inc.

1 recall record in Other.

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1 recall grouped by year

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2015

1 record

Class IITerminatedRecall F-1380-2015

Product description

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.

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Event ID
70097
Code info
Lot 62110, exp. date 04/2015
Product quantity
581 units
Distribution pattern
NJ, OH, TX, LA, and Puerto Rico
Voluntary / mandated
Voluntary: Firm initiated
Initial firm notification
Letter
Product type
Food
Recalling firm location
369 Bayview Ave, N/A, Amityville, NY, United States
Recall initiation date
12/23/2014
Center classification date
03/03/2015
Termination date
05/08/2017