Class II · Moderate risk
Lidocaine HCL Visc 2% 100ml
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
Ofloxacin 0.3% 5ml Opth
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Fenofibrate Capsules
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Methocarbamol 500mg 500
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Synthroid (levothyroxine sodium tablets, USP)
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Norvir Ritonavir Tablets 100 mg 30 Tablets Rx only NDC…
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Orilissa elagolix tablets 150 mg per tablet equivalent to 155.2 mg elagolix sodium
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Creon (pancrelipase)
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Niacin 250mg 110
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Therapeutic M 130
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class III · Low risk
Tremfya (guselkumab)
Temperature Abuse
Class III · Low risk
Methacholine Challenge 5-Syringe Test Kits
Temperature Abuse; labeled with the incorrect room temperature (15-25 ¿C) storage conditions rather than the correct refrigerated (2 - 8 ¿C) storage conditions
Class III · Low risk
Famotidine Injection
TEMPERATURE ABUSE: Complaint received from customer that product was received in a non-refrigerated state.
Class III · Low risk
Zilretta (triamcinolone acetonide extended-release injectable suspension)
Temperature Abuse: Product was stored at room temperature longer than 6 weeks and was inadvertently distributed instead of discarded
Class II · Moderate risk
Nucala (mepolizumab)
Temperature Abuse; Product stored and shipped outside of labeled storage requirements.
Class III · Low risk
Clotrimazole and Betamethasone Dipropionate Cream USP
Temperature Abuse: Complaints received of liquidy texture.
Class II · Moderate risk
Admelog Solostar
Temperature Abuse: Product samples of Admelog may not have been shipped at proper temperature.
Class II · Moderate risk
Valacyclovir Tablets USP 1 gram
Temperature Abuse: Valganciclovir Tablets USP 450 mg and Valacyclovir Tablets USP 1 gram were exposed to higher temperature at airport or cargo and in the same consignment of Famciclovir complaint batch (D-0415-2018).
Class II · Moderate risk
Valganciclovir Tablets
Temperature Abuse: Valganciclovir Tablets USP 450 mg and Valacyclovir Tablets USP 1 gram were exposed to higher temperature at airport or cargo and in the same consignment of Famciclovir complaint batch (D-0415-2018).
Class II · Moderate risk
Famciclovir Tablets
Temperature Abuse: Complaints of tablets being wet and stuck together with tablet coating peeled and disintegrated as a result of prolonged exposure to high temp during distribution.
Class I · High risk
Intralipid 20%
Temperature Abuse: A portion of this product lot was exposed to subfreezing temperatures, which is outside of the acceptable storage range listed on the product labeling, during transit to a distribution facility.
Class III · Low risk
AndroGel (testosterone gel)
Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.
Class III · Low risk
AndroGel (testosterone gel)
Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.
Class III · Low risk
Phentermine
Failed Impurities/Degradation Specification; out-of-specification results for individual unknown impurities at the 30 month Room Temperature Retained Sample stability test
Class II · Moderate risk
hydrALAZINE HYDROCHLORIDE INJECTION
Temperature Abuse: Certain pieces of these lots distributed by McKesson Medical Surgical Inc. were inadvertently stored refrigerated rather than the labeled room temperature recommendation.
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