Class II · Moderate risk
Advil Liqui-Gels Solubilized Ibuprofen Capsules
CGMP deviation: product outside labeled storage temperature requirements.
Robitussin Cough N Chest Congestion 4 Fl Oz Sku 919471 Delsym…
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
ROBITUSSIN COUGH N CHEST CONGESTION 4 FL OZ SKU 919471 DELSYM ORANGE 3 FL OZ SKU 901880 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
- Recalling firm
- Family Dollar Stores, Llc.
- Origin
- VA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1453-2022 · 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 recalls by Family Dollar Stores, Llc.
All 2022 recalls
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.
Other temperature excursion recalls from 2022
All temperature excursion recalls
Class II · Moderate risk
Colgate Whitening Mouthwash
cGMP deviation: Product held outside of appropriate temperature storage conditions.
Class II · Moderate risk
Colgate Anticavity Fluoride Toothpaste OPTIC WHITE STAIN FIGHTER…
cGMP deviation: Product held outside of appropriate temperature storage conditions.
Class II · Moderate risk
Colgate Anticavity Fluoride Toothpaste
cGMP deviation: Product held outside of appropriate temperature storage conditions.
Class II · Moderate risk
Colgate Anticavity Fluoride Toothpaste
cGMP deviation: Product held outside of appropriate temperature storage conditions.
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