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

FDA recall notice · announced March 11, 2015 · Hi-tech Pharmacal Co

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Notes

Distribution: NJ, OH, TX, LA, and Puerto Rico
Lot/code information: Lot 62110, exp. date 04/2015
Quantity: 581 units
Status: Terminated
Products in this recall event:
- FERROUS SULFATE ELIXIR 220 mg/5 mL, UPC 350838778059, NDC 50383-778-05 --- HI-TECH PHARMACAL CO, INC. AMITYVILLE, NY 11701 (F-1380-2015)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.