Class II · Moderate risk
Children's Ibuprofen Oral Suspension
Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product.
Motrin Ib Caplets 24ct Sku999394
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: product held outside appropriate storage temperature conditions.
Cause type: Temperature excursion
The product was stored or shipped outside its labeled temperature range. Heat or freezing can degrade a drug without any visible change, so it may be weaker than labeled. All temperature excursion recalls.
What was recalled
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:
Drug: Ibuprofen Category: Pain Relief & OTC Medication
- Recalling firm
- Family Dollar Stores, Llc.
- Origin
- VA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1373-2022 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other Ibuprofen recalls
See all
Class II · Moderate risk
Advil a) Ibuprofen
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Class II · Moderate risk
Acetaminophen and Ibuprofen
CGMP Deviations
Class III · Low risk
IBU (ibuprofen)
Failed Tablet/Capsule Specifications
Class II · Moderate risk
Ibuprofen 800mg
Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-month stability testing.
Other recalls by Family Dollar Stores, Llc.
All 2022 recalls
Class II · Moderate risk
Advil Liqui-Gels Solubilized Ibuprofen Capsules
CGMP deviation: product outside labeled storage temperature requirements.
Class II · Moderate risk
Advil Dual Action with Acetaminophen Acetaminophen 250 mg and Ibuprofen
CGMP deviation: product outside labeled storage temperature requirements.
Class II · Moderate risk
Advil Ibuprofen Tablets
CGMP deviation: product outside labeled storage temperature requirements.
Class II · Moderate risk
Advil Ibuprofen Tablets
CGMP deviation: product outside labeled storage temperature requirements.
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