Why it was recalled
Microbial Contamination of Non-Sterile Products: product failed bioburden testing for Total Aerobic Microbial Count.
Product description
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.
Lot numbers, UPCs & expiration codes
Lots: 19027D, 19027E, Exp 07/21
Where it was sold
One distributor who further distributed Nationwide 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-1879-2019
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Aug 30, 2019
- FDA report date
- Sep 18, 2019
- Quantity
- 1,433 cases
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Plastikon Healthcare LLC
Original FDA data
Every field from FDA enforcement report D-1879-2019, exactly as published.
Show all FDA fields
- City
- Lawrence
- State
- KS
- Status
- Terminated
- Country
- United States
- Event ID
- 83693
- Address
- 3780 Greenway Cir
- Code information
- Lots: 19027D, 19027E, Exp 07/21
- Postal code
- 66046-5440
- Report date
- Sep 18, 2019
- Product type
- Drugs
- Recall number
- D-1879-2019
- Classification
- Class I
- Recalling firm
- Plastikon Healthcare LLC
- Product quantity
- 1,433 cases
- Termination date
- Nov 4, 2020
- Reason for recall
- Microbial Contamination of Non-Sterile Products: product failed bioburden testing for Total Aerobic Microbial Count.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- One distributor who further distributed Nationwide in the USA.
- Recall initiation date
- Aug 30, 2019
- Initial firm notification
- Letter
- Center classification date
- Sep 24, 2019