Why it was recalled
CGMP Deviations: OTC products were stored outside of labeled temperature requirements.
Product description
Certain Over-The-Counter (OTC) drug products sold by Family Dollar retail stores.
Lot numbers, UPCs & expiration codes
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.
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0045-2024
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Oct 5, 2023
- FDA report date
- Oct 25, 2023
- Quantity
- 4,261,383 units of various products
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Dollar Tree Distribution, Inc.
Original FDA data
Every field from FDA enforcement report D-0045-2024, exactly as published.
Show all FDA fields
- City
- Chesapeake
- State
- VA
- Status
- Ongoing
- Country
- United States
- Event ID
- 93187
- Address
- 500 Volvo Pkwy
- 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.
- Postal code
- 23320-1604
- Report date
- Oct 25, 2023
- Product type
- Drugs
- Recall number
- D-0045-2024
- Classification
- Class II
- Recalling firm
- Dollar Tree Distribution, Inc.
- Product quantity
- 4,261,383 units of various products
- Reason for recall
- CGMP Deviations: OTC products were stored outside of labeled temperature requirements.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Certain Over-The-Counter (OTC) drug products sold by Family Dollar retail stores.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Oct 5, 2023
- Initial firm notification
- Press Release
- Center classification date
- Oct 16, 2023