💊 Drugs • 12,141 recalls
Anabolic Science Labs
Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of synthetic hormone/prohormone (methylated anabolic steroid) ingredient making them unapproved new drugs.
Physician Preferred Medical
Non-Sterility: The recalled lot failed sterility testing.
Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of synthetic hormone/prohormone (methylated anabolic steroid) ingredient making them unapproved new drugs.
Chemical Contamination: Product recalled due to an elevated level of a residual solvent impurity in the API that exceeds the Threshold of Toxicological Concern (TTC) calculation for the impurity.
Teva Pharmaceuticals USA
Chemical Contamination: Product recalled due to an elevated level of a residual solvent impurity in the API that exceeds the Threshold of Toxicological Concern (TTC) calculation for the impurity.
Crystallization
Crystallization
Presence of Particulate Matter; Hospira has identified the particulate as a human hair, sealed in the bag at the additive port area.
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Lack of Sterility Assurance: The product has the potential to leak at the administrative port.
Presence of particulate.
Defective container: A customer complaint revealed the presence of a defective seal on the top of a Mucinex pouch
Subpotent Drug: Flurandrenolide is subpotent.
Actavis Laboratories, FL
Presence of Foreign Substance; fine residue or dust identified as aluminum may be on exterior of the capsule shell
CGMP Deviations: Product excipient was not re-tested at the appropriate date.
Labeling: Incorrect or Missing Package Insert: the package insert for the potassium chloride 8 mEq and 10 mEq strength instead of the potassium chloride 10 mEq and 20 mEq strength was packaged with the product.
Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.
Central Admixture Pharmacy Services
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Failed Impurities/Degradation Specifications: A stability lot was out of specification for a known impurity at the 8 month Controlled Room Temperature stability time-point.
Non-Sterility: Out of specification results for the sterility test for microbial contamination.