Plastikon Healthcare LLC: Drug Recall
Recall #D-1482-2022 · 06/07/2022
Class II: Risk
Recall Details
- Recall Number
- D-1482-2022
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Plastikon Healthcare LLC
- Status
- Terminated
- Date Initiated
- 06/07/2022
- Location
- Lawrence, KS, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 521,700 cups
Reason for Recall
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Product Description
Magnesium Hydroxide 1200 mg, Aluminum Hydroxide 1200 mg, Simethicone 120 mg per 30 mL, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-6838-73
Distribution Pattern
Distributed Nationwide in the USA
Other Recalls by Plastikon Healthcare LLC
- Class II: Risk 06/07/2022
- Class II: Risk 06/07/2022
- Class II: Risk 06/07/2022
- Class II: Risk 06/07/2022
- Class II: Risk 06/07/2022
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.