Lack of Assurance of Sterility: There are also CGMP Deviations.
Prescription Drugs
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Lack of Assurance of Sterility: There are also CGMP Deviations.
Lack of Assurance of Sterility: There are also CGMP Deviations.
Lack of Assurance of Sterility: There are also CGMP Deviations.
Lack of Assurance of Sterility: There are also CGMP Deviations.
Lack of Assurance of Sterility: There are also CGMP Deviations.
Lack of Assurance of Sterility: There are also CGMP Deviations.
Lack of Assurance of Sterility: There are also CGMP Deviations.
Lack of Assurance of Sterility: There are also CGMP Deviations.
Lack of Assurance of Sterility: There are also CGMP Deviations.
Triamcinolone 40 mg/mL 2 mL Single-Dose Vial for Injection, Preservative Free, Rx only, Compounded by Isomeric Pharmacy Solutions, Salt Lake City, UT 84109, NDC 70285-1920-1
Isomeric Pharmacy Solution
CGMP Deviations
Lack of Assurance of Sterility: There are also CGMP Deviations.
Lack of Assurance of Sterility: There are also CGMP Deviations.
BICARBONATE 10%, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Synergy Rx
Lack of Assurance of Sterility: There are also CGMP Deviations.
Lack of Assurance of Sterility: There are also CGMP Deviations.
Lack of Assurance of Sterility: There are also CGMP Deviations.
Lack of Assurance of Sterility: There are also CGMP Deviations.
Failed Dissolution Specifications
Failed Impurities/ Degradation Specifications: OOS for related compound (levofloxacin n-oxide) at the 18 month stability time point.
Risedronate Sodium Delayed-release Tablets, 35 mg, Once-a-Week, 1 tablet per blister (NDC 0093-5509-19), packaged in 4 blisters per carton (NDC 0093-5509-44), Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454.
Teva Pharmaceuticals USA
Failed Dissolution Specifications: low out of specification dissolution results found during stability testing.