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Class II: temporary or reversible health riskOngoing

Family Dollar Stores Motrin Ib Caplets 24ct Sku999394 Recall

MOTRIN IB CAPLETS 24CT SKU999394

Family Dollar Stores, Llc. · Chesapeake, VA

Risk level
Class II
Reported by FDA
Aug 31, 2022
Recall ID
D-1373-2022
Check your lot numberHow we source this data

Summary

Family Dollar Stores recalled Motrin Ib Caplets 24ct Sku999394 starting Jun 23, 2022. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1373-2022 on Aug 31, 2022. Reason: CGMP Deviations: product held outside appropriate storage temperature conditions. Status: Ongoing.

Why it was recalled

CGMP Deviations: product held outside appropriate storage temperature conditions.

Product description

MOTRIN IB CAPLETS 24CT SKU999394; GOOD SENSE IBUPROFEN 200MG TABLETS 24CT SKU 900556;GOOD SENSE IBUPROFEN 200MG CAPLET 50 CT SKU 902333 MOTRIN CHILDREN'S BUBBLEGUM 4 FL OZ SKU 903048 GOOD SENSE IBUPROFEN REGULAR SOFTGELS 160CT SKU 999373 GOOD SENSE IBUPROFEN 200 MG CAPLET 100 CT SKU 902359 MOTRIN IB CAPLET 50 CT SKU 900604 GOOD SENSE IBUPROFEN IB CAPLET 100 CT SKU 913989 GOOD SENSE IBUPROFEN 200 MG SOFTGEL 20CT SKU 916994 ADVIL LIQUID GEL 40 CT SKU 916071 GOOD SENSE IBUPROFEN PM 200 MG 20 CT SKU 917004 ADVIL PM CAPLET 20CT SKU 913010 GOOD SENSE IBUPROFEN TABLET 100 CT SKU 913991 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. Specifically:

Lot numbers, UPCs & expiration codes

SKUs: 999394; 900556; 902333; 903048; 999373; 902359; 900604 913989; 916994; 916071; 917004; 913010; 913991

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-1373-2022
Classification
Class II
Status
Ongoing
Recall initiated
Jun 23, 2022
FDA report date
Aug 31, 2022
Recall type
Voluntary: Firm initiated
Recalling firm
Family Dollar Stores, Llc.

Original FDA data

Every field from FDA enforcement report D-1373-2022, exactly as published.

Show all FDA fields
City
Chesapeake
State
VA
Status
Ongoing
Country
United States
Event ID
90566
Address
500 Volvo Pkwy
Code information
SKUs: 999394; 900556; 902333; 903048; 999373; 902359; 900604 913989; 916994; 916071; 917004; 913010; 913991
Postal code
23320-1604
Report date
Aug 31, 2022
Product type
Drugs
Recall number
D-1373-2022
Classification
Class II
Recalling firm
Family Dollar Stores, Llc.
Reason for recall
CGMP Deviations: product held outside appropriate storage temperature conditions.
Voluntary / mandated
Voluntary: Firm initiated
Product description
MOTRIN IB CAPLETS 24CT SKU999394; GOOD SENSE IBUPROFEN 200MG TABLETS 24CT SKU 900556;GOOD SENSE IBUPROFEN 200MG CAPLET 50 CT SKU 902333 MOTRIN CHILDREN'S BUBBLEGUM 4 FL OZ SKU 903048 GOOD SENSE IBUPROFEN REGULAR SOFTGELS 160CT SKU 999373 GOOD SENSE IBUPROFEN 200 MG CAPLET 100 CT SKU 902359 MOTRIN IB CAPLET 50 CT SKU 900604 GOOD SENSE IBUPROFEN IB CAPLET 100 CT SKU 913989 GOOD SENSE IBUPROFEN 200 MG SOFTGEL 20CT SKU 916994 ADVIL LIQUID GEL 40 CT SKU 916071 GOOD SENSE IBUPROFEN PM 200 MG 20 CT SKU 917004 ADVIL PM CAPLET 20CT SKU 913010 GOOD SENSE IBUPROFEN TABLET 100 CT SKU 913991 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. Specifically:
Distribution pattern
Nationwide within the United States
Recall initiation date
Jun 23, 2022
Initial firm notification
Other
Center classification date
Aug 22, 2022

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1373-2022, published Aug 31, 2022. View the source record (openFDA) · FDA enforcement reports

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

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