Drug recall
Antacid Liquid Regular Strength Antacid & Anti-Gas (Aluminum hydroxide 200 mg, Magnesium hydroxide 200 mg…
FDA recall event 70577 · Class II · Tarmac Products, Inc.
Key facts
| Event ID | 70577 |
|---|---|
| Recall numbers | D-0418-2015, D-0419-2015 |
| Recalling firm | Tarmac Products, Inc. |
| Product type | Drugs |
| Products | Antacid Liquid Regular Strength Antacid & Anti-Gas (Aluminum hydroxide 200 mg, Magnesium hydroxide 200 mg, Simethicone 20 mg (in each 5 mL, 1 teaspoon), Mint flavor, 12 fl oz (355 mL) bottle…, Comfort Gel Maximum Strength Antacid & Anti-Gas (Aluminum hydroxide 400 mg, Magnesium hydroxide 400 mg, Simethicone 40 mg in each 5 mL, 1 teaspoon) liquid, 12 FL OZ (355 mL) bottle, Distributed By… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Microbial Contamination of Non-Sterile Products: Lots failed microbiological testing at the 12-month time point. |
| Initiation date | Feb 6, 2015 |
| Report date | Mar 25, 2015 |
| Termination date | Dec 30, 2016 |
| City | Miami Gardens |
| State | FL |
| Country | United States |
| FEI number | 1025483 |
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: