Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
All Recalls
95,064 total recalls in our database
Lack of assurance of sterility.
CGMP Deviations: Detection of trace amounts of NDMA, a possible impurity or contaminant in an active pharmaceutical ingredient.
Methylcobalamin 10 mg vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009
Pharmcore
Lack of assurance of sterility.
Failed Dissolution Specifications: manufacturer West-Ward Pharm Corp. recalled these repackaged lots due to failed dissolution results.
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Lack of assurance of sterility.
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Calcitriol Oral Solution, 1 mcg/mL, 15 mL bottle, Rx Only, Distributed by: Ranbaxy Pharmaceuticals Inc. Jacksonville, FL 32257 USA, NDC 63304-241-59
Validus Pharmaceuticals
Subpotency: lower than expected potency result was obtained at the 18 month stability time point.
Ipamorelin 9 mg vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009
Pharmcore
Lack of assurance of sterility.
Lack of assurance of sterility.
Lack of assurance of sterility.
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Lack of assurance of sterility.
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.