Diphenhydramine Solution Recalled Due to Manufacturing Control Deviations
Plastikon Healthcare LLC is recalling Diphenhydramine HCl Oral Solution nationwide due to manufacturing control deficiencies that did not meet Current Good Manufacturing Practice standards.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for pharmaceutical manufacturing control deficiencies affecting nationwide distribution. No illnesses or injuries have been reported, placing it in the risk-of-harm category without confirmed harm, per the rubric maximum of 3 for theoretical hazards.
Plain-English summary
Plastikon Healthcare LLC is recalling Diphenhydramine HCl Oral Solution 12.5 mg / 5 mL in pre-measured 5 mL cups due to manufacturing control deviations. The FDA determined that the product was manufactured under conditions that did not adequately control manufacturing processes, as required by Current Good Manufacturing Practice (CGMP) regulations.
The recalled product was distributed nationwide throughout the United States to institutional users. The affected lots include multiple batches with expiration dates ranging from June 2022 through October 2023, representing approximately 217,700 individual cups.
Institutional users should immediately stop using the recalled product and contact Plastikon Healthcare LLC or their distributor for return and replacement options. No illnesses or injuries related to this recall have been reported to date.
The recalled product
- Product
- 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
- Manufacturer
- Plastikon Healthcare LLC
- Category
- Drug
- Hazard
- manufacturing-control-deficiency
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (14)
- 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.
Distribution
Distributed nationwide across the United States.
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