Why it was recalled
CGMP Deviations: Failure to properly investigate failed microbial testing.
Product description
MILK OF MAGNESIA USP, (Magnesium Hydroxide), 2400 mg/30 mL, 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 0904-6846-73.
Lot numbers, UPCs & expiration codes
Lot: 20041A, 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-0870-2022
- Classification
- Class II
- Status
- Completed
- Recall initiated
- Mar 24, 2022
- FDA report date
- May 25, 2022
- Quantity
- 5,400 Unit Dose cups
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Plastikon Healthcare LLC
Original FDA data
Every field from FDA enforcement report D-0870-2022, 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: 20041A, EXP May 2022
- Postal code
- 66046-5440
- Report date
- May 25, 2022
- Product type
- Drugs
- Recall number
- D-0870-2022
- Classification
- Class II
- Recalling firm
- Plastikon Healthcare LLC
- Product quantity
- 5,400 Unit Dose cups
- Reason for recall
- CGMP Deviations: Failure to properly investigate failed microbial testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- MILK OF MAGNESIA USP, (Magnesium Hydroxide), 2400 mg/30 mL, 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 0904-6846-73.
- 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