💊 Drugs • 12,141 recalls
Sun Pharma Global Fze
Failed Dissolution Specifications: 6 month time point.
Presence of Particulate Matter: Confirmed customer complaint that orange and black particulates, identified as iron oxide, were found embedded within the glass vial and floating in solution.
Presence of Foreign Substance: Presence of blue plastic floating in loratadine syrup.
Lack of Assurance of Sterility: Complaints of leaks due to an incomplete seal at the bag seam.
Walgreens Infusion Services
Lack of sterility assurance.
3M Company/3m Espe Dental Products
Labeling: Incorrect or Missing Lot and/or Exp. Date - The subject lot is missing the lot number and expiration date stamp on the primary box..
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices
Valeant Pharmaceuticals North America
Non-Sterility: Valeant's laboratory observed a positive microbial contamination of Virazole lot 340353F, during testing at the 12 month stability pull.
SCA Pharmaceuticals
Labeling: Incorrect or missing Lot and/or Exp Date: Printing error caused an overlap in the "y" and "3" making the actual "Use By 3/2015" date appear to read "Use By8/2015".
Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and breaking of capsules with some bottles showing popped out bottle bottom (round bottom) and creased labels from one distribution center.
Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and breaking of capsules with some bottles showing popped out bottle bottom (round bottom) and creased labels from one distribution center.
Lack of Assurance of Sterility: The product has the potential for solution to leak at the administrative port.
Failed Impurities/Degradation Specifications: High out of specification results for the known impurity p-Aminophenol.
Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and breaking of capsules with some bottles showing popped out bottle bottom (round bottom) and creased labels from one distribution center.
Incorrect Product Formulation: An incorrect gas was used to remove the oxygen from the vial.
Par Pharmaceutical
Presence of Foreign Substance: Par Pharmaceutical, Inc. is recalling one lot of HydrALAZINE Hydrochloride tablets due to the presence of small aluminum particles.
Failed Tablet/Capsule Specifications: Complaints of empty capsules received.
Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared dexamethasone and cyproheptadine which are FDA approved drugs making this product an unapproved drug.
Vann Healthcare Services
Lack of Assurance of Sterility: A recent FDA inspection of Vann Healthcare Services facility revealed deficiencies that raise concerns about the pharmacy's ability to consistently assure sterility of their products.