D-0618-2022 Class II Terminated
FDA drug recall D-0618-2022 was initiated by Perrigo Company PLC on October 26, 2021 and is designated Class II. Reason for recall: CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. The recall status is terminated (terminated September 29, 2023). Affected quantity: 41,472 bottles.
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
- 41,472 bottles
Product Description
Soothing 12 Hour Nasal Decongestant Spray No Drip, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, Distributed By MAJOR PHARMACEUTICALS, 17177 N Laurel Park Drive, Suite 233 Livonia, MI 48152. NDC 0904-6761-30
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: 1BK0826, Exp 12/31/2022; 1FK1164, Exp 01/31/2023