Why it was recalled
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Product description
Diphenhydramine HCl Oral Solution, 25 mg / 10 mL, 10 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 0904-6741-72
Lot numbers, UPCs & expiration codes
Lot # 20065A, EXP Jun. 2022; 20068A, 20070A, EXP Jul. 2022; 20097A, 20098A, EXP Oct. 2022; 21055A, EXP May. 2023; 21083A, EXP Jul. 2023; 21091A, EXP Aug. 2023; 21112A, EXP Oct. 2023
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-1489-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 7, 2022
- FDA report date
- Sep 14, 2022
- Quantity
- 349,100 cups
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Plastikon Healthcare LLC
Original FDA data
Every field from FDA enforcement report D-1489-2022, 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 # 20065A, EXP Jun. 2022; 20068A, 20070A, EXP Jul. 2022; 20097A, 20098A, EXP Oct. 2022; 21055A, EXP May. 2023; 21083A, EXP Jul. 2023; 21091A, EXP Aug. 2023; 21112A, EXP Oct. 2023
- Postal code
- 66046-5440
- Report date
- Sep 14, 2022
- Product type
- Drugs
- Recall number
- D-1489-2022
- Classification
- Class II
- Recalling firm
- Plastikon Healthcare LLC
- Product quantity
- 349,100 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
- Diphenhydramine HCl Oral Solution, 25 mg / 10 mL, 10 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 0904-6741-72
- 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