FDA-Food2015-03-11Class II

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

Hi-Tech Pharmacal Co., Inc.
Hazard

Out-of-specification result for pH observed during stability testing of Ferrous Sulfate Elixir, 5 mL unit dose, Lot 621120.

Sold states
NJ, OH, TX, LA, and Puerto Rico
Affected count
581 units
Manufactured in
369 Bayview Ave, N/A, Amityville, NY, United States
Products
FERROUS SULFATE ELIXIR 220 mg/5 mL, UPC 350838778059, NDC 50383-778-05 --- HI-TECH PHARMACAL CO, INC. AMITYVILLE, NY 11701

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=F-1380-2015

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