FDA recalls · F-1380-2015
Hi-Tech Pharmacal Co., Inc. recall
- FoodFERROUS SULFATE ELIXIR 220 mg/5 mL, UPC 350838778059, NDC 50383-778-05 --- HI-TECH PHARMACAL CO, INC. AMITYVILLE, NY 11701
- ReasonOut-of-specification result for pH observed during stability testing of Ferrous Sulfate Elixir, 5 mL unit dose, Lot 621120.
- ClassClass II: the food could cause temporary or treatable health problems
- StatusClosed by FDA, ended 2017-05-08
- DatesFirm started it 2014-12-23. In FDA's enforcement report 2015-03-11.
- Sold inNJ, OH, TX, LA, and Puerto Rico
- Amount581 units
- CodesLot 62110, exp. date 04/2015
- FirmHi-Tech Pharmacal Co., Inc., Amityville, NY · Voluntary: Firm initiated
Products we list
None. We tie a recall to a product only by a barcode printed in the recall, and this one names none we list. That does not mean the recalled food is missing from our listings.
From FDA's enforcement report, via openFDA (CC0): raw data for this recall. FDA's own Enforcement Report search finds it by its number, F-1380-2015. Class meanings: FDA.