Prescription and over-the-counter medications
PharMEDium Services
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Herbal Doctor Remedies
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Herbal Doctor Remedies
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Herbal Doctor Remedies
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Herbal Doctor Remedies
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
The Medicine Shoppe Pharmacy
Lack of Assurance of Sterility
Medical Center Pharmacy
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Lupin Pharmaceuticals
Presence of Foreign Tablet/ Capsule: Product complaint received indicating mix-up of one lisinopril 5mg tablet inside of a 30 mg, 100-count bottle of Lisinopril Tablets.
Failed Impurities/Degradation Specification: Presence of unknown impurity observed.
Medical Center Pharmacy
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Medical Center Pharmacy
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Medical Center Pharmacy
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Medical Center Pharmacy
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Y-O Management LLC
Marketed without an Approved NDA/ANDA: FDA analysis found this product to contain undeclared Tadalafil, an FDA approved drug for the treatment of erectile dysfunction
Failed impurities/degradation specification: Out-of-Specification result for total impurity at 4.1% (Limit: NMT 3.0%) during retained sample testing.
Dr. Reddy's Laboratories
Defective Container: Recall is due to breaking and shattering of ampules upon opening
Nostrum Laboratories
CGMP Deviations: poor manufacturing practices resulted in Labeling: Incorrect or Missing Lot and/or Exp Date, product incorrectly labeled with incorrect lot and expiration date.
Subpotent Drug
Failed Stability Specifications
Mylan Pharmaceuticals
Presence of foreign tablet/capsule - Potential presence of commingled one Tacrolimus 1 mg capsule in 5 mg bottles.