Why it was recalled
CGMP Deviations: Failure to properly investigate failed microbial testing.
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.
Lot numbers, UPCs & expiration codes
Lot: 20042A, 20043A, 20045A, 20046A, 20047A, EXP May 2022
Where it was sold
Distributed in Indiana for further distribution in the USA.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0871-2022
- Classification
- Class II
- Status
- Completed
- Recall initiated
- Mar 24, 2022
- FDA report date
- May 25, 2022
- Quantity
- 106,400 Unit Dose cups
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Plastikon Healthcare LLC
Original FDA data
Every field from FDA enforcement report D-0871-2022, exactly as published.
Show all FDA fields
- City
- Lawrence
- State
- KS
- Status
- Completed
- Country
- United States
- Event ID
- 89879
- Address
- 3780 Greenway Cir
- Code information
- Lot: 20042A, 20043A, 20045A, 20046A, 20047A, EXP May 2022
- Postal code
- 66046-5440
- Report date
- May 25, 2022
- Product type
- Drugs
- Recall number
- D-0871-2022
- Classification
- Class II
- Recalling firm
- Plastikon Healthcare LLC
- Product quantity
- 106,400 Unit Dose cups
- Reason for recall
- CGMP Deviations: Failure to properly investigate failed microbial testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Distributed in Indiana for further distribution in the USA.
- Recall initiation date
- Mar 24, 2022
- Initial firm notification
- Press Release
- Center classification date
- May 13, 2022