Hi-Tech Pharmacal Co., Inc. recalls FERROUS SULFATE ELIXIR 220 mg/5 mL, UPC 350838778059, NDC 50383-778-05 --- HI-TECH PHARMACAL CO, INC. AMITYVILLE, NY 11…
- Recall date
- December 23, 2014
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- F-1380-2015
- FDA classification
- Class II
- Brand / firm
- Hi-Tech Pharmacal Co., Inc.
- Sold / distributed
- NJ, OH, TX, LA, and Puerto Rico
Why it was recalled
Out-of-specification result for pH observed during stability testing of Ferrous Sulfate Elixir, 5 mL unit dose, Lot 621120.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
FERROUS SULFATE ELIXIR 220 mg/5 mL, UPC 350838778059, NDC 50383-778-05 --- HI-TECH PHARMACAL CO, INC. AMITYVILLE, NY 11701
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