[Recalled] 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… | FDA 2014-12-23
The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.
Recall details
| Product | FERROUS SULFATE ELIXIR 220 mg/5 mL, UPC 350838778059, NDC 50383-778-05 --- HI-TECH PHARMACAL CO, INC. AMITYVILLE, NY 11701 |
|---|---|
| Brand / manufacturer | Hi-Tech Pharmacal Co., Inc. |
| Category | food |
| Issuing authority | FDA_FOOD |
| Reference | F-1380-2015 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 23 December 2014 |
| EAN / barcode | 350838778059 |
Why it was recalled
According to the FDA_FOOD notice, the identified hazard is: Out-of-specification result for pH observed during stability testing of Ferrous Sulfate Elixir, 5 mL unit dose, Lot 621120.
This Class II recall concerns food products distributed in United States and was recorded by FDA_FOOD. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from Hi-Tech Pharmacal Co., Inc.
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.
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