Status
Ongoing
Drug Enforcement D-0563-2023
CGMP deviation: product outside labeled storage temperature requirements.
Classification
Class II
Report Date
May 10, 2023
Termination Date
—
Product Information
- 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.
- Product quantity
- Pending.
- Reason for recall
- CGMP deviation: product outside labeled storage temperature requirements.
- Recall initiation reason
- —
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution pattern
- Nationwide within the United States
Location & Firm
- Recalling firm
- Family Dollar Stores, Llc.
- Address
-
500 Volvo Pkwy
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0563-2023
- Event ID
- 92248
- Recall initiation date
- March 31, 2023
- Center classification date
- May 4, 2023
- Code info
- SKUs a) 0901458; b) 0913023; c) 0999259 stored and distributed from DCs 07/28/2022 through 03/31/2023.
- More code info
- —