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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 217,700
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.
Part of a larger recall action
This product is one of 19 recalled by Plastikon Healthcare LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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