Reported Sep 14, 2022 · Terminated
GUAIFENESIN AND DEXTROMETHORPHAN 100 mg-10 mg/5 mL, 5 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?
- GUAIFENESIN AND DEXTROMETHORPHAN 100 mg-10 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 0904-6844-70
- Lot codes and dates
Lot # 20091AEXP Sep. 202220104AEXP Nov. 202221013AEXP Feb. 202321041AEXP Apr. 202321102AEXP Sep. 202321121A21127AEXP Nov. 202322003A22007AEXP Jan. 202422016AEXP Mar. 2024
- Amount recalled
- 280,500 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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