Recalls / Class I
Class ID-1479-2022
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
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, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-6839-73
- Affected lot / code info
- Lot #: 20051A, EXP Aug. 2022; 20088A, EXP Sep. 2022.
Why it was recalled
Microbial Contamination of Non-Sterile Products.
Recalling firm
- Firm
- Plastikon Healthcare LLC
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 3780 Greenway Cir, N/A, Lawrence, Kansas 66046-5440
Distribution
- Quantity
- 43,200 cups
- Distribution pattern
- Distributed Nationwide in the USA
Timeline
- Recall initiated
- 2022-06-07
- FDA classified
- 2022-09-06
- Posted by FDA
- 2022-09-14
- Terminated
- 2025-06-25
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1479-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.