Plastikon Healthcare LLC: Drug Recall
Recall #D-1489-2022 · 06/07/2022
Class II: Risk
Recall Details
- Recall Number
- D-1489-2022
- 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
- 349,100 cups
Reason for Recall
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Product Description
Diphenhydramine HCl Oral Solution, 25 mg / 10 mL, 10 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 0904-6741-72
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.