Home / Recalls / Perrigo Company PLC / D-0349-2022

D-0349-2022 Class II Terminated

Recalled by Perrigo Company PLC — Allegan, MI

Recall Details

Product Type
Drugs
Report Date
January 12, 2022
Initiation Date
July 27, 2021
Termination Date
November 8, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
26,304 containers

Product Description

TopCare Allergy Relief, Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 12 count bottle, Distributed Topco Associates LC, Elk Grove Village, IL 60007, Made in the Czech Republic, NDC 36800-954-53 UPC 0 36800 33284 3

Reason for Recall

Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.

Distribution Pattern

Nationwide in the USA

Code Information

Lot # 0LE2178, Exp 01/31/2022

Other recalls by Perrigo Company PLC

  • D-0596-2022 Class II — Acetaminophen Infant Dye Free Grape Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) (October 26, 2021)
  • D-0595-2022 Class II — Acetaminophen Infant Dye Free Grape Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) (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-0581-2022 Class II — Children's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 4 FL OZ (11 (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-0588-2022 Class II — Acetaminophen Child Dye Free Cherry Flavor Oral Suspension (160mg/5ml), 4 FL OZ (October 26, 2021)