FDA Recall D-1879-2019
Plastikon Healthcare LLC · Lawrence, KS
Class I — life-threatening Terminated 432 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
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, NDC 0904-6846-73.
Reason for recall
Microbial Contamination of Non-Sterile Products: product failed bioburden testing for Total Aerobic Microbial Count.
Recall record
- Recall number
D-1879-2019- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- One distributor who further distributed Nationwide in the USA.
- Recall initiated
- 2019-08-30
- Classified by FDA Center
- 2019-09-24
- FDA published
- 2019-09-18
- Terminated
- 2020-11-04
- Recalling firm
- Plastikon Healthcare LLC
- Firm location
- Lawrence, KS