Why it was recalled
Microbial Contamination of Non-Sterile Products.
Product description
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
Lot numbers, UPCs & expiration codes
Lot #: 20051A, EXP Aug. 2022; 20088A, EXP Sep. 2022.
Where it was sold
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-1479-2022
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Jun 7, 2022
- FDA report date
- Sep 14, 2022
- Quantity
- 43,200 cups
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Plastikon Healthcare LLC
Original FDA data
Every field from FDA enforcement report D-1479-2022, exactly as published.
Show all FDA fields
- City
- Lawrence
- State
- KS
- Status
- Terminated
- Country
- United States
- Event ID
- 90398
- Address
- 3780 Greenway Cir
- Code information
- Lot #: 20051A, EXP Aug. 2022; 20088A, EXP Sep. 2022.
- Postal code
- 66046-5440
- Report date
- Sep 14, 2022
- Product type
- Drugs
- Recall number
- D-1479-2022
- Classification
- Class I
- Recalling firm
- Plastikon Healthcare LLC
- Product quantity
- 43,200 cups
- Termination date
- Jun 25, 2025
- Reason for recall
- Microbial Contamination of Non-Sterile Products.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Distributed Nationwide in the USA
- Recall initiation date
- Jun 7, 2022
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Sep 6, 2022