Home / Recalls / Perrigo Company PLC / D-0337-2022

D-0337-2022 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
12,384 containers

Product Description

Health Mart, Fexofenadine Hydrochloride tablets, 12HR, 60mg . Antihistamine 12 count bottle, Distributed by: Mckesson 6555 State Highway 161, Irvine, TX 75039. Made in the Czech Republic, NDC 62011-0413-1, UPC 0 52569 14278 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 0JE2491, Exp 1/31/2022

Other recalls by Perrigo Company PLC

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  • 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)