CGMP deviations- Lack of Quality Assurance
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Prescription Drugs
💊 Drugs • 12,141 recalls
methylcobalamin 1mg/1mL, vial for injection, Rx only, MedPark Pharmacy 2002 Medical Pkwy. # 170 Annapolis, MD 21401
MedPark Pharmacy
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
Failed Dissolution Specifications: out of specification results observed for low dissolution.
Class I - Dangerous
Lack of assurance of sterility: Product bags leaking at seam.
Class I - Dangerous
Lack of assurance of sterility: Product bags leaking at seam.
Class I - Dangerous
Lack of assurance of sterility: Product bags leaking at seam.
Class I - Dangerous
Lack of assurance of sterility: Product bags leaking at seam.
Failed Impurities/Degradation Specifications: Presence of an impurity peak that exceeds approved specification.
Class I - Dangerous
Lack of assurance of sterility: Product bags leaking at seam.
Class I - Dangerous
Lack of assurance of sterility: Product bags leaking at seam.
Class I - Dangerous
Lack of assurance of sterility: Product bags leaking at seam.
Class I - Dangerous
Lack of assurance of sterility: Product bags leaking at seam.
Class I - Dangerous
Subpotent Drug; Clavulanic Acid
Class I - Dangerous
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
Class I - Dangerous
Lack of assurance of sterility: Product bags leaking at seam.
Succinylcholine Chloride all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
Advanced Pharma
Class I - Dangerous
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
cGMP Deviations: lack of quality assurance at the API manufacturer.
Class I - Dangerous
Chemical Contamination: out of specification results for impurities were found to be the result of contamination of product from vapors associated with paint thinner used in repair of the manufacturing room.
Epinephrine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
Advanced Pharma
Class I - Dangerous
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.