Lack of assurance of sterility
All Recalls
95,018 total recalls in our database
CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
Lack of assurance of sterility
Marketed Without An Unapproved NDA/ANDA: Product lot found to be tainted with undeclared diclofenac, an FDA approved nonsteroidal anti-inflammatory drug (NSAID) for the treatment of pain and inflammation.
Streptococcinum, Potency: 8C, 9C, 30C, 200C, Liquid Pellets, Rx only, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411
Washington Homeopathic Products
cGMP deviations
Diphtherinum, Potency: 14C, 30C, 200C, Liquid Pellets, Rx only, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411,
Washington Homeopathic Products
cGMP deviations
Medorrhinum, Potency:12C, 30C, 200C, 1M, Liquid Pellets, Rx only, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411
Washington Homeopathic Products
cGMP deviations
Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent for ethanol.
Pyrogenium, Potency: 15X, 16X, 17X, 19X, 21X, 22X, 25X, 30X, 1M, 200C, 30C, OTC, Liquid Pellets, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411
Washington Homeopathic Products
cGMP deviations
CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
Bacillinum Pulmo, Potency: 30C, 200C, Liquid Pellets, Rx only, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411
Washington Homeopathic Products
cGMP deviations
Lack of assurance of sterility
Pertussinum, Potency: 19C, 30C, 200C, 1M, Liquid Pellets, OTC, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411
Washington Homeopathic Products
cGMP deviations
Candida Albicans, Potency: 9C, 10C, 12C, 13C, 14C 15C 16C, 19C, 24C, 25C, 26C, 30C, 200C, 14X, 15X, 16X, 20X, 288X, 30X, Liquid Pellets, OTC, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411
Washington Homeopathic Products
cGMP deviations
Influenzinum, Potency: 9X, 10X, 12X, 15X, 25X, 30X, 200C, 12C, 30C 1M, Liquid Pellets, OTC, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411
Washington Homeopathic Products
cGMP deviations
Candida Parapsilosis, Potency: 14X, 15X, 16X, 20X, 28X, 30X, 9C, 10C, 13C, 15C, 25C, 30C, 13X, 27X, 30X, Liquid Pellets, OTC, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411
Washington Homeopathic Products
cGMP deviations
t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM, and t:slim X2 Insulin Pump with Basal-IQ Technology
Tandem Diabetes Care
Insulin pumps may display unexpected fluctuation of the remaining battery life so ensure pump battery life does not fall below 25% remaining power. If the battery life drops to less than 5%, insulin delivery will continue for 30 minutes and then the pump will power off and insulin delivery will stop. If the battery reaches 1%, then insulin delivery will stop, which could lead to hyperglycemia.
Drager SafeStar 55, Catalog No. MP01790
Draeger Medical
Possible occlusion of filters due to manufacturing error.
AXIUM DETACHABLE COIL SYSTEM REF QC-4-12-HELIX; Axium Detachable Coil System REF QC-10-30-3D;
Micro Therapeutics
Due to incorrect size and configuration labeling of the detachable coil system.
Due to a potential failed sterilization process.