Drug recall
Alka-Seltzer Extra Strength (500 mg Aspirin (NSAID), 1985 mg Analgesic Sodium bicarbonate/Antacid, 1000 mg…
FDA recall event 77484 · Class II · Bayer HealthCare Pharmaceuticals, Inc.
Key facts
| Event ID | 77484 |
|---|---|
| Recall numbers | D-1044-2017, D-1050-2017, D-1051-2017 |
| Recalling firm | Bayer HealthCare Pharmaceuticals, Inc. |
| Product type | Drugs |
| Products | Alka-Seltzer Extra Strength (500 mg Aspirin (NSAID), 1985 mg Analgesic Sodium bicarbonate/Antacid, 1000 mg Anhydrous Citric Acid) Effervescent Tablets, 24-count carton, Made in Germany, Distributed by…, Alka-Seltzer Gold (1000 mg Anhydrous citric acid, 344 mg Antacid Potassium bicarbonate, 1050 mg Antacid Sodium bicarbonate/Antacid) Effervescent Tablets, 36-count carton, Made in Germany, Distributed…, Alka-Seltzer Original ( 325 mg Aspirin (NSAID), 1916 mg Analgesic, Sodium bicarbonate/Antacid, 1000 mg Anhydrous Citric Acid) Effervescent Tablets, 12-count carton, Made in Germany, Distributed by… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs. |
| Initiation date | Mar 30, 2017 |
| Report date | Aug 9, 2017 |
| Termination date | Jan 8, 2020 |
| City | Morristown |
| State | NJ |
| Country | United States |
| FEI number | 2243252 |
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: