Presence of Foreign Substance: human hair melded into tablet.
Drugs Recalls
Prescription and over-the-counter medications
CGMP deviations- Lack of Quality Assurance
Levonorgestrel, U.S.P. active pharmaceutical ingredient, packaged in 1 kg container, Rx only, Spectrum Chemical Mfg. Corp, Gardena, CA 90248, New Brunswick, NJ 08901, Product code L1229.
Spectrum Laboratory Products
CGMP Deviations: these repackaged and redistributed products are being recalled due to a recall notice from the active pharmaceutical ingredient manufacturer for deviations from current Good Manufacturing Practices that were found during a recent FDA inspection.
Failed Dissolution Specifications: out of specification results observed for low dissolution.
CGMP deviations- Lack of Quality Assurance
methylcobalamin 1mg/1mL, vial for injection, Rx only, MedPark Pharmacy 2002 Medical Pkwy. # 170 Annapolis, MD 21401
MedPark Pharmacy
Lack of Assurance of Sterility
Failed Dissolution Specifications: out of specification results observed for low dissolution.
Lack of assurance of sterility: Product bags leaking at seam.
Lack of assurance of sterility: Product bags leaking at seam.
Lack of assurance of sterility: Product bags leaking at seam.
Lack of assurance of sterility: Product bags leaking at seam.
Failed Impurities/Degradation Specifications: Presence of an impurity peak that exceeds approved specification.
Lack of assurance of sterility: Product bags leaking at seam.
Lack of assurance of sterility: Product bags leaking at seam.
Lack of assurance of sterility: Product bags leaking at seam.
Lack of assurance of sterility: Product bags leaking at seam.
Subpotent Drug; Clavulanic Acid
Lack of assurance of sterility: Product bags leaking at seam.
Labeling; Label Mixup; blister lidding foil and shell-pack labeled as 10 mg but package actually contains 5 mg tablets
Lack of assurance of sterility: Product bags leaking at seam.