Rugby Childrens Acetaminophen Suspension
FDA Recall NDC 0536-1321
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Rugby Childrens Acetaminophen (NDC 0536-1321). A significant event, classified as Class II, was initiated on Oct 26, 2021 by Rugby Laboratories. The reported reason for this action was: "CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Oct 26, 2021
Mar 02, 2022
4,992 bottles
Recall Profile & Regulatory Data
Event ID
88905
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Perrigo Company PLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Sep 29, 2023
Product Description
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
Batch or Lot Expiration Information
Batch# Batch: 1BK0960, Exp 12/31/2022
Affected Packages Involved in this Recall
0536-1321-97Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
