FDA recall F-1380-2015

Hi-Tech Pharmacal Co., Inc. · Class II · food

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

Key facts

Status
Terminated
Initiation date
2014-12-23
Report date
2015-03-11
Termination date
2017-05-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
Amityville, NY, United States

Primary source

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