Why it was recalled
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Product description
Magnesium Hydroxide 1200 mg, Aluminum Hydroxide 1200 mg, Simethicone 120 mg per 30 mL, 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 0904-6838-73
Lot numbers, UPCs & expiration codes
Lot # 20077A, 20080A, 20082A, EXP Aug. 2022; 21016A, EXP Feb. 2023; 21026A, EXP Mar. 2023; 21042A, 21047A, 21050A, EXP Apr. 2023; 21057A, 21059A, 21060A,EXP May. 2023; 21061A, 21067A, 21070A, 21072A, EXP Jun. 2023; 21095A, 21097A, 21099A, EXP Sep. 2023; 21107A, 21109A, 21111A, 21113A, EXP Oct. 2023; 21138A, EXP Dec. 2023; 22002A, 22004A, 22005A, EXP Jan. 2024
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-1482-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 7, 2022
- FDA report date
- Sep 14, 2022
- Quantity
- 521,700 cups
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Plastikon Healthcare LLC
Original FDA data
Every field from FDA enforcement report D-1482-2022, 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 # 20077A, 20080A, 20082A, EXP Aug. 2022; 21016A, EXP Feb. 2023; 21026A, EXP Mar. 2023; 21042A, 21047A, 21050A, EXP Apr. 2023; 21057A, 21059A, 21060A,EXP May. 2023; 21061A, 21067A, 21070A, 21072A, EXP Jun. 2023; 21095A, 21097A, 21099A, EXP Sep. 2023; 21107A, 21109A, 21111A, 21113A, EXP Oct. 2023; 21138A, EXP Dec. 2023; 22002A, 22004A, 22005A, EXP Jan. 2024
- Postal code
- 66046-5440
- Report date
- Sep 14, 2022
- Product type
- Drugs
- Recall number
- D-1482-2022
- Classification
- Class II
- Recalling firm
- Plastikon Healthcare LLC
- Product quantity
- 521,700 cups
- Termination date
- Jun 25, 2025
- Reason for recall
- CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Magnesium Hydroxide 1200 mg, Aluminum Hydroxide 1200 mg, Simethicone 120 mg per 30 mL, 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 0904-6838-73
- 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