D-0617-2022 Class II Terminated
FDA drug recall D-0617-2022 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: 7,632 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
- 7,632 bottles
Product Description
Nasal Spray Decongestant, No Drip, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202. NDC 30142-388-10
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: 1BK0826, Exp 12/31/2022