D-0611-2022 Class II Terminated
FDA drug recall D-0611-2022 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: 89,208 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
- 89,208 bottles
Product Description
Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, Dist. by Target Corp., Mpls., MN 55403. NDC 11673-935-10
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: 1BK0912, Exp 12/31/2022; 1FK1251, Exp 02/28/2023