Drug recall
FERROUS SULFATE ELIXIR 220 mg/5 mL, UPC 350838778059, NDC 50383-778-05 --- HI-TECH PHARMACAL CO, INC…
FDA recall event 70097 · Class II · Hi-Tech Pharmacal Co., Inc.
Key facts
| Event ID | 70097 |
|---|---|
| Recall numbers | F-1380-2015 |
| Recalling firm | Hi-Tech Pharmacal Co., Inc. |
| Product type | Food |
| Products | FERROUS SULFATE ELIXIR 220 mg/5 mL, UPC 350838778059, NDC 50383-778-05 --- HI-TECH PHARMACAL CO, INC. AMITYVILLE, NY 11701 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Out-of-specification result for pH observed during stability testing of Ferrous Sulfate Elixir, 5 mL unit dose, Lot 621120. |
| Initiation date | Dec 23, 2014 |
| Report date | Mar 11, 2015 |
| Termination date | May 8, 2017 |
| City | Amityville |
| State | NY |
| Country | United States |
| FEI number | 2433247 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: