Class II · Moderate risk
Hydrogen Peroxide 16 fl. oz. and 32 oz. bottles distributed to…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Temperature excursions
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.
569 FDA drug recalls with this cause, newest first.
Vaccines, insulin, many injectables and some tablets must stay within a narrow temperature band from factory to pharmacy. A truck without working refrigeration, a freezer failure or a warehouse heatwave is enough: the product looks normal but may have lost potency or formed degradation products. FDA files these under 'CGMP deviations' or 'temperature abuse'; we track them separately because the question to ask - how was my medication stored? - is different from every other cause.
Class II · Moderate risk
Listerine Cool mint Mouthwash 250 mL SKU 900733 Crest Scope…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk
Colgate Max Fresh Clean Mint 1.9oz Sku 900596 Colgate Cavity…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk
Dermasil Dry Skin Treatment 10 OZ SKU 2098068 Aveeno Daily…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk
Banana Boat Sprt Clr Spry Spf50 6 Fl Oz Sku 2007524 Suntone…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk
AMBI Skin Cream for normal skin 2 OZ SKU 2024219 AMBI Skin…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk
Novelty Hand Sanitizer with Silicone Wrap SKU 998890 Novelty…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk
Aveeno Daily Moisturizing lotion Fragrance Free with Soothing Oat & Rich Emollients
cGMP deviations: product stored outside of labeled temperature requirements.
Class II · Moderate risk
Luxury Hygiene Hand Sanitizer Moisturizing Formula with Vitamin E
cGMP deviations: product stored outside of labeled temperature requirements.
Class II · Moderate risk
Luxury Hygiene Hand Sanitizer Moisturizing Formula with Vitamin E Advanced Aloe Vera
cGMP deviations: product stored outside of labeled temperature requirements.
Class II · Moderate risk
AMBI Skincare Even & Clear Exfoliating Wash Salicylic Acid Acne…
cGMP deviations: product stored outside of labeled temperature requirements.
Class II · Moderate risk
AMBI Skincare Fade Cream Oily Skin New & Improved
cGMP deviations: product stored outside of labeled temperature requirements.
Class II · Moderate risk
AMBI Skincare Fade Cream Normal Skin
cGMP deviations: product stored outside of labeled temperature requirements.
Class II · Moderate risk
Only At Family Dollar AMBI Skincare Even & Clear Nourishing Daily…
cGMP deviations: product stored outside of labeled temperature requirements.
Class II · Moderate risk
Paracentesis/Thoracentises Tray
cGMP deviations: Temperature abuse
Class II · Moderate risk
Biopsy and Aspiration Tray Bone Marrow Illinois 11GX4
cGMP deviations: Temperature abuse
Class II · Moderate risk
Intralipid
cGMP deviations: Temperature abuse
Class II · Moderate risk
Intralipid
cGMP deviations: Temperature abuse
Class II · Moderate risk
Cefazolin for injection USP
cGMP deviations: Temperature abuse
Class II · Moderate risk
Cefazolin for injection USP
cGMP deviations: Temperature abuse
Class II · Moderate risk
Diprivan (Propofol)
cGMP deviations: Temperature abuse
Class II · Moderate risk
Diprivan (Propofol)
cGMP deviations: Temperature abuse
Class II · Moderate risk
Ofloxacin Otic Solution 0.3%
cGMP deviations: Temperature abuse
Class II · Moderate risk
Tetracaine Hydrochloride Ophthalmic Solution
cGMP deviations: Temperature abuse
Class II · Moderate risk
Geodon for injection
cGMP deviations: Temperature abuse
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