D-0563-2023 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- May 10, 2023
- Initiation Date
- March 31, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Pending.
Product Description
Advil Ibuprofen Tablets, 200 mg Pain Reliever/Fever Reducer (NSAID) packaged in a) 100-count bottles, b) 50-count bottles, and c) 3 (2 count) packets.
Reason for Recall
CGMP deviation: product outside labeled storage temperature requirements.
Distribution Pattern
Nationwide within the United States
Code Information
SKUs a) 0901458; b) 0913023; c) 0999259 stored and distributed from DCs 07/28/2022 through 03/31/2023.