FDAFDA · Food and drugs·Recall number D-1488-2022
Diphenhydramine HCl Oral Solution 12.5 mg / 5 mL, 5 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 0904-6740-70
Published September 14, 2022 · Recall initiated: June 7, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Plastikon Healthcare LLC
- Distributor
- Distributed Nationwide in the USA
- Lot
- Lot # 20063A, EXP Jun. 2022; 20098A, EXP Oct. 2022; 21055B, EXP May. 2023; 21066A, EXP Jun. 2023; 21083B, EXP Jul. 2023; 21112B, EXP Oct. 2023; 22009A, EXP Feb. 2024.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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