Home / Recalls / Perrigo Company PLC / D-1014-2020

D-1014-2020 Class II Terminated

Recalled by Perrigo Company PLC — Allegan, MI

Recall Details

Product Type
Drugs
Report Date
March 25, 2020
Initiation Date
October 23, 2019
Termination Date
November 6, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity

Product Description

Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 80 tablets per bottle. [NDC: Brand] NDC Basic Care: 0113-7876-27; NDC CVS Health: 69842-293-27; NDC Leader: 70000-0375-2; NDC Up & Up: 11673-876-27; NDC Walgreens: 0363-1876-27

Reason for Recall

CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.

Distribution Pattern

Nationwide USA

Code Information

Lots: 8CE1643, 8DE1370, 8DE1768, 8EE1560, 8FE1452, 8GE1341, 8HE1223, 8KE2832, 8KE2246, 8ME2725, 9AE2835, 9CE3378, 9DE2748, 9EE2637, 9FE2976, 9GE2795, 9GE3228, 9HE3617

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  • D-0621-2022 Class II — Maximum Strength No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant (October 26, 2021)
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  • 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)