Class II · Moderate risk
Amlodipine and Olmesartan Medoxomil Tablets 10 mg/20 mg 30…
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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
Tri-Lo-Marzia 0.180mg/0.025mg
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
NOHIST-DM Antihistamine/Antitussive Nasal Decongestant 16 fl. oz.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Pantoprazole Sodium Delayed-Release Tablets
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Siladryl 12.5/5ml 118ml Sf Af
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Ferrous Sulfate 75 mg
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Infants Aqueous Vitamin D Oral Drops 400 IU/mL 50 mL
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Phentermine HCL 37.5mg 100 C4
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Phentermine HCL 30mg 100 C4
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Livalo (pitavastatin)
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Auryxia (ferric citrate)
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Invega Sustenna 156mg/1ml
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Tylenol Acetaminophen Pain Regular Strength Liquid Gels Pain…
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Enbrace HR 30 ct. Softgels Enhanced Prenatal Vitamin Supplement…
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
TIROSINT (levothyroxine sodium)
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Levofloxacin Injection in 5% Dextrose 500 mg in 100 mL 5% Dextrose
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Leucovorin 15mg 24
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Lithium Carb 150mg 100
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Calcium Acetate Capsules 667 mg 200 Capsules Rx only NDC…
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
AcetaZOLAMIDE Tablets
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
bupropion Hydrochloride Tablets
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
FaBB Vitamin B6
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Hydrocortisone Ointment USP 1% Maximum Strength Net Wt. 1 oz
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Triumeq (abacavir, dolutegravir, and lamivudine)
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Theophylline
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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