FDA recall record
FERROUS SULFATE ELIXIR 220 mg/5 mL, UPC 350838778059, NDC 50383-778-05 --- HI-TECH PHARMACAL CO, INC. AMITYVILLE, NY 11701
FDA classification. FDA Class I, II, and III are not the same as USDA FSIS classifications and are not a cross-agency safety score.
FDA listed a termination date of May 8, 2017. openFDA does not treat this as a live recall-status tracker.
Product described in an FDA recall
FERROUS SULFATE ELIXIR 220 mg/5 mL, UPC 350838778059, NDC 50383-778-05 --- HI-TECH PHARMACAL CO, INC. AMITYVILLE, NY 11701
Reason
Out-of-specification result for pH observed during stability testing of Ferrous Sulfate Elixir, 5 mL unit dose, Lot 621120.
Products involved
Product descriptions are copied from the FDA recall record. They are not a current catalog and are not automatically matched to WhoMadeMyFood product pages.
FERROUS SULFATE ELIXIR 220 mg/5 mL, UPC 350838778059, NDC 50383-778-05 --- HI-TECH PHARMACAL CO, INC. AMITYVILLE, NY 11701
Code information listed by FDA
Lot 62110, exp. date 04/2015
Distribution and firm information
Recalling firm listed by FDA: Hi-Tech Pharmacal Co., Inc.
Firm location listed by FDA: Amityville, NY, United States
Distribution reported by FDA: NJ, OH, TX, LA, and Puerto Rico
Product quantity listed by FDA: 581 units
Source
Source: U.S. Food and Drug Administration (FDA), openFDA food enforcement reports.
Official FDA openFDA food enforcement record
Identifying an FDA recall record does not imply FDA endorsement of WhoMadeMyFood. Methodology.