Home / Recalls / Perrigo Company PLC / D-0581-2022

D-0581-2022 Class II Terminated

Recalled by Perrigo Company PLC — Allegan, MI

Recall Details

Product Type
Drugs
Report Date
March 2, 2022
Initiation Date
October 26, 2021
Termination Date
September 29, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4,992 bottles

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

Reason for Recall

CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

Distribution Pattern

Nationwide in the USA

Code Information

Batch: 1BK0960, Exp 12/31/2022

Other recalls by Perrigo Company PLC

  • D-0595-2022 Class II — Acetaminophen Infant Dye Free Grape Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) (October 26, 2021)
  • D-0588-2022 Class II — Acetaminophen Child Dye Free Cherry Flavor Oral Suspension (160mg/5ml), 4 FL OZ (October 26, 2021)
  • D-0600-2022 Class II — Children's Pain & Fever Acetaminophen, 160 mg per 5 mL Oral Suspension combo pac (October 26, 2021)
  • D-0596-2022 Class II — Acetaminophen Infant Dye Free Grape Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) (October 26, 2021)
  • D-0579-2022 Class II — Acetaminophen Oral Suspension Grape Flavor, 160 mg per 5 mL, 16 fl oz (473 mL) p (October 26, 2021)
  • D-0616-2022 Class II — Maxiumum Strength No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestan (October 26, 2021)
  • D-0621-2022 Class II — Maximum Strength No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant (October 26, 2021)
  • D-0609-2022 Class II — Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05%, 1 (October 26, 2021)
  • D-0617-2022 Class II — Nasal Spray Decongestant, No Drip, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per (October 26, 2021)
  • D-0590-2022 Class II — Children's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 4 FL OZ (11 (October 26, 2021)