PlainRecalls
FDA Food Moderate Class II Terminated

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

Reported: March 11, 2015 Initiated: December 23, 2014 #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.

Details

Units Affected
581 units
Distribution
NJ, OH, TX, LA, and Puerto Rico
Location
Amityville, NY

Frequently Asked Questions

What product was recalled?
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.. Units affected: 581 units.
Why was this product recalled?
Out-of-specification result for pH observed during stability testing of Ferrous Sulfate Elixir, 5 mL unit dose, Lot 621120.
Which agency issued this recall?
This recall was issued by the FDA Food on March 11, 2015. Severity: Moderate. Recall number: F-1380-2015.