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Class II: temporary or reversible health riskOngoing

Family Dollar Stores Advil Ibuprofen Tablets Recall

Advil Ibuprofen Tablets, 200 mg Pain Reliever/Fever Reducer (NSAID) packaged in a) 100-…

Family Dollar Stores, Llc. · Chesapeake, VA

Risk level
Class II
Reported by FDA
May 10, 2023
Recall ID
D-0563-2023
Check your lot numberHow we source this data

Summary

Family Dollar Stores recalled Advil Ibuprofen Tablets starting Mar 31, 2023. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0563-2023 on May 10, 2023. Reason: CGMP deviation: product outside labeled storage temperature requirements. Status: Ongoing.

Why it was recalled

CGMP deviation: product outside labeled storage temperature requirements.

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.

Lot numbers, UPCs & expiration codes

SKUs a) 0901458; b) 0913023; c) 0999259 stored and distributed from DCs 07/28/2022 through 03/31/2023.

Where it was sold

Nationwide within the United States

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-0563-2023
Classification
Class II
Status
Ongoing
Recall initiated
Mar 31, 2023
FDA report date
May 10, 2023
Quantity
Pending.
Recall type
Voluntary: Firm initiated
Recalling firm
Family Dollar Stores, Llc.

Original FDA data

Every field from FDA enforcement report D-0563-2023, exactly as published.

Show all FDA fields
City
Chesapeake
State
VA
Status
Ongoing
Country
United States
Event ID
92248
Address
500 Volvo Pkwy
Code information
SKUs a) 0901458; b) 0913023; c) 0999259 stored and distributed from DCs 07/28/2022 through 03/31/2023.
Postal code
23320-1604
Report date
May 10, 2023
Product type
Drugs
Recall number
D-0563-2023
Classification
Class II
Recalling firm
Family Dollar Stores, Llc.
Product quantity
Pending.
Reason for recall
CGMP deviation: product outside labeled storage temperature requirements.
Voluntary / mandated
Voluntary: Firm initiated
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.
Distribution pattern
Nationwide within the United States
Recall initiation date
Mar 31, 2023
Initial firm notification
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Center classification date
May 4, 2023

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0563-2023, published May 10, 2023. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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