Lawrence, KS, United States
Plastikon Healthcare LLC recalls
3 recalls recorded since 2018, most recently on 7 June 2022. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)0
Terminated or completed3
Class I (FDA)3
Terminated Class I, Class II Drugs
- Recall started
- 7 June 2022
- Terminated
- 25 June 2025
- Reason
- CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
- Distribution
- Distributed Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-1488-2022, D-1489-2022, D-1484-2022, D-1485-2022, D-1481-2022, D-1483-2022, D-1493-2022, D-1486-2022, D-1477-2022, D-1478-2022, D-1487-2022, D-1482-2022 and 7 more
- Diphenhydramine HCl Oral Solution 12.5 mg / 5 mL, 5 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
- 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
- Acetaminophen Oral Solution 160 mg / 5 mL, 5 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-
- Acetaminophen Oral Solution, 325 mg / 10.15 mL, 10.15 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, ND
- MILK OF MAGNESIA USP, 2400 mg/10 mL, Magnesium Hydroxide, 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 4
- Magnesium Hydroxide 2400 mg, Aluminum Hydroxide 2400 mg, Simethicone 240 mg MAX, per 30 mL Oral Suspension, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals,
- CORRECTDOSE Children's PAIN RELIEF & Fever Reducer, Cherry, (Acetaminophen 160 mg per 5 mL), 2.04 FL.OZ (60mL), packaged in 12-5mL individual doses, Distributed by Correct Dose Inc, Braintree MA 02184. NDC 62320-311-05
- Acetaminophen Oral Solution 650 mg / 20.3 mL, 20.3 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 0
- and 11 more product lines
Completed Class I, Class II Drugs
- Recall started
- 24 March 2022
- Reason
- Microbial Contamination of Non-Sterile Products
- Distribution
- Distributed in Indiana for further distribution in the USA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0868-2022, D-0867-2022, D-0869-2022, D-0871-2022, D-0870-2022
- Magnesium Hydroxide 1200mg, Aluminum Hydroxide 1200mg, Simethicone 120mg, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distribute by Major Pharmaceuticals, Livonia, MI 48152,
- MILK OF MAGNESIA USP, (Magnesium Hydroxide), 2400 mg/30 mL, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distributed by Major Pharmaceuticals, Livonia, MI 48152, NDC 0904-6846
- Acetaminophen Oral Solution, USP 650mg/ 20.3 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distributed by Major Pharmaceuticals, Livonia, MI 48152, NDC: 0904-6820-76.
- Magnesium Hydroxide 1200mg, Aluminum Hydroxide 1200mg, Simethicone 120mg, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distributed by Major Pharmaceuticals, Livonia, MI 48152,
- MILK OF MAGNESIA USP, (Magnesium Hydroxide), 2400 mg/30 mL, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distributed by Major Pharmaceuticals, Livonia, MI 48152, NDC 0904-6846
Terminated Class I Drugs
- Recall started
- 30 August 2019
- Terminated
- 4 November 2020
- Reason
- Microbial Contamination of Non-Sterile Products: product failed bioburden testing for Total Aerobic Microbial Count.
- Distribution
- One distributor who further distributed Nationwide in the USA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1879-2019
- Milk of Magnesia USP, 2400 mg/30 mL, Magnesium Hydroxide 2400 mg, 30 mL unit dose cups, For Institutional Use Only, packaged in 100-count cartons of 10 trays x 10 unit dose cups, Major Pharmaceuticals, Livonia, MI 48152,
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.