Class II · Moderate risk
Colgate Whitening Mouthwash
cGMP deviation: Product held outside of appropriate temperature storage 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
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.
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.
Class II · Moderate risk
Acetaminophen Injection
Temperature Abuse: Product distributed in refrigerated trucks with labels attached to pallets indicating "Refrigerate Upon Arrival", however product is labeled to be stored in a controlled room temperature environment.
Class II · Moderate risk
VICKS DAYQUIL NYQUIL LIQ COMB PK 6 FLOZ distributed to specific…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk
QP COUGH COLD TABLET 16 CT distributed to specific Family Dollar…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk
MUCINEX SE MAX STRENGTH 7CT distributed to specific Family Dollar…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk
QP COLD MULTI SYMPTM DAY NITE CPLT 24 CT distributed to specific…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk
HYLANDS 4KIDS COLD N MUCUS RELIEF 4 FL OZ distributed to specific…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk
MUCINEX FASTMAX CAPLETS COLD FLU 4CT distributed to specific…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk
Refenesen Mucus Relief Tablet 30 Ct Sku 917531 Mucinex Dm Max…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk
QP SUDFEDRINE PE MAX STRENGTH TBLT 24 CT distributed to specific…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk
Dayquil Cold Flu Lqd 12 Fl Oz Sku 900205 Ric Night Time Cld Flu…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk
Robitussin Cough N Chest Congestion 4 Fl Oz Sku 919471 Delsym…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk
Ready in Case Ctrzne Alrgy All Dy Tblt 5 Ct Sku 900448 Zyrtec…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk
Claritin Allergy Liq Chldrns Grape 2 Floz Sku 900834 Claritin…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk
Qp Dphnhdrme Alrgy Min Tblt 12 Ct Sku 900449 Qp Allergy…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk
Gs Anti Diarrheal Loperamide Caplet 12 Ct Sku 915632 Imodium Ad…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk
Guardian Bismuth Chwble Chry Tabs 30 Ctsku 902321 Ric Bismuth…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk
JOHNSONS BABY FIRST TOUCH GIFT SET 4PC distributed to specific…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk
EXCEDRIN MIGRAINE CAPLET 24 CT distributed to specific Family…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk
NICORETTE GUM WHITE ICE MINT 4 MG 20 CT distributed to specific…
CGMP Deviations: product held outside appropriate storage temperature conditions.
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