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, NDC: 0904-6838-73.
Reported: May 25, 2022 Initiated: March 24, 2022 #D-0871-2022
Product Description
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, NDC: 0904-6838-73.
Reason for Recall
CGMP Deviations: Failure to properly investigate failed microbial testing.
Details
- Recalling Firm
- Plastikon Healthcare LLC
- Units Affected
- 106,400 Unit Dose cups
- Distribution
- Distributed in Indiana for further distribution in the USA.
- Location
- Lawrence, KS
Frequently Asked Questions
What product was recalled? ▼
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, NDC: 0904-6838-73.. Recalled by Plastikon Healthcare LLC. Units affected: 106,400 Unit Dose cups.
Why was this product recalled? ▼
CGMP Deviations: Failure to properly investigate failed microbial testing.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 25, 2022. Severity: Moderate. Recall number: D-0871-2022.
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