Drug product
Certain Over-The-Counter (OTC) drug products sold by Family Dollar retail stores.
D-0045-2024
Product summary
- Event
- Event 93187
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 4,261,383 units of various products
- Official record key
drug-enforcement:D-0045-2024
Official wording
Reason: CGMP Deviations: OTC products were stored outside of labeled temperature requirements.
Code information: Certain drug products sold by Family Dollar retail stores located in AL, AR, AZ, CA, CO, FL, GA, ID, KS, LA, MS, MT, ND, NE, NM, NV, OK, OR, SD, TX, UT, WA, and WY.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations