Hi-Tech Pharmacal recalled Ferrous Sulfate Elixir due to out-of-specification pH results during stability testing. This manufacturing defect may affect the product's safety and efficacy for consumers.
Class II — Eating this product may cause temporary or medically reversible health problems; serious harm is unlikely.
FERROUS SULFATE ELIXIR 220 mg/5 mL, UPC 350838778059, NDC 50383-778-05 --- HI-TECH PHARMACAL CO, INC. AMITYVILLE, NY 11701
Out-of-specification result for pH observed during stability testing of Ferrous Sulfate Elixir, 5 mL unit dose, Lot 621120.
| Recall # | Product | Lot / code | Status |
|---|---|---|---|
| F-1380-2015 | FERROUS SULFATE ELIXIR 220 mg/5 mL, UPC 350838778059, NDC 50383-778-05 --- HI-TECH PHARMACAL CO, INC. AMITYVILLE, NY 11701 | Lot 62110, exp. date 04/2015 | Terminated |
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