D-0616-2022 Class II Terminated
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
- 123,408 bottles
Product Description
Maxiumum Strength No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY OLD EAST MAIN CO., 100 MISSION RIDGE, GOODLETTSVILLE, TN 37072. NDC 55910-623-10
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); 1FK1232, 1BK0964, Exp 01/31/2023