Reported Sep 14, 2022 · Terminated
Diphenhydramine HCl Oral Solution, 25 mg / 10 mL, 10 mL cup, packaged in 10 cups per tray, 10 trays per carton, For…
Plastikon Healthcare LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Plastikon Healthcare LLC · 3780 Greenway Cir · Lawrence, KS · 66046-5440
Is this the product you have?
Diphenhydramine HCl Oral Solution25 mg / 10 mL10 mL cuppackaged in 10 cups per tray10 trays per cartonFor Institutional Use OnlyMajor Pharmaceuticals17177 N Laurel Park Dr. Suite 233LivoniaMI 48152NDC 0904-6741-72
- Lot codes and dates
Lot # 20065AEXP Jun. 202220068A20070AEXP Jul. 202220097A20098AEXP Oct. 202221055AEXP May. 202321083AEXP Jul. 202321091AEXP Aug. 202321112AEXP Oct. 2023
- Amount recalled
- 349,100 cups
This recall covers 19 products
The agency filed one notice per product. You are reading one of them; the other 18 are below.
6 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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