Recalls / Class I
Class ID-1879-2019
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences 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.
- Affected lot / code info
- Lots: 19027D, 19027E, Exp 07/21
Why it was recalled
Microbial Contamination of Non-Sterile Products: product failed bioburden testing for Total Aerobic Microbial Count.
Recalling firm
- Firm
- Plastikon Healthcare LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 3780 Greenway Cir, Lawrence, Kansas 66046-5440
Distribution
- Quantity
- 1,433 cases
- Distribution pattern
- One distributor who further distributed Nationwide in the USA.
Timeline
- Recall initiated
- 2019-08-30
- FDA classified
- 2019-09-24
- Posted by FDA
- 2019-09-18
- Terminated
- 2020-11-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1879-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.