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

Recall map → All recalls → F-1380-2015

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. · reported 2015-03-11

Terminated This recall has been closed out by the agency.

Reason for recall: Out-of-specification result for pH observed during stability testing of Ferrous Sulfate Elixir, 5 mL unit dose, Lot 621120.
Classification: Class II
Recall initiated: 2014-12-23
Reported by the agency: 2015-03-11
Closed out (terminated): 2017-05-08
Recalling firm: Hi-Tech Pharmacal Co., Inc.
Amityville, NY
United States
This is the firm that issued the recall — commonly a distributor or processor. It is not the origin of contamination.
Distribution (the agency's own words): NJ, OH, TX, LA, and Puerto Rico
States we parsed from that text: LA NJ OH PR TX
The agency named these states. Parse method explicit_state_list, confidence high.
Food category: uncategorised
Assigned by a reviewed keyword rulebook over the product description, not by the agency.
Recall type: Voluntary: Firm initiated
Recall number: F-1380-2015

This page reproduces a record published by the US Food and Drug Administration. It is not real-time: recalls typically appear in FDA's Enforcement Report weeks after they begin — a median of 40 days, see publication lag. For current food safety information consult FDA and USDA FSIS directly.