FDAFDA · Food and drugs·Recall number D-0581-2022
Children's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, Distributed by: Rugby Laboratories, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152. NDC: 0536-1321-97
Published March 2, 2022 · Recall initiated: October 26, 2021
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 were manufactured with contaminated excipient that was recalled from the excipient supplier.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- RUGBY CHILDRENS ACETAMINOPHEN
- Manufacturer
- Perrigo Company PLC
- Distributor
- Nationwide in the USA
- Lot
- Batch: 1BK0960, Exp 12/31/2022
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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