Class II · Moderate risk Terminated
Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), 1,000 mL Single Dose bag, packaged in 1000 mL…
Reason Lack of Assurance of Sterility
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Class III · Low risk Terminated
Loteprednol Etabonate Ophthalmic Suspension, 5 mg/mL (0.5%), packaged as one bottle in a carton in a) 10 mL bottle (NDC#…
Reason Superpotent Drug: Out of Specification (OOS) results observed for unit dose content.
Class II · Moderate risk Terminated
0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA…
Reason Lack of assurance of sterility: bags have the potential to leak.
Class II · Moderate risk Terminated
Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx only, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ…
Reason Failed Moisture Limits: Water (moisture) content above the approved product specifications.
Class II · Moderate risk Terminated
Bivalirudin for Injection 250 mg, 10 Single-Dose Vials, Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703…
Reason Presence of Particulate Matter: Particulate matter identified as fiber.
Class II · Moderate risk Terminated
Atropine Sulfate Injection, USP 8 mg per 20 mL (0.4 mg per mL), 20 mL Multiple Dose Vials, Rx only, Manufactured for: Accord…
Reason Presence of Particulate Matter: Particulate matter identified as fiber.
Class I · High risk Terminated
Albuterol Sulfate Inhalation Aerosol, 90 mcg, 200 Metered Inhalation, net content 6.7 g canister packaged in a box, Rx only…
Reason Defective container: empty inhaler and leakage observed through the inhaler valve due to partially missing bottom seat (gasket).
Class III · Low risk Terminated
Amlodipine Besylate Tablets, USP 10 mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore…
Reason Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study.
Class II · Moderate risk Terminated
Losartan Potassium Tablets, USP, 25 mg, 1000 film coated tablets per bottle, Rx Only, Manufactured by: Vivimed Life Sciences…
Reason Presence of Foreign Substance: Presence of a small piece of blue plastic embedded in the tablet.
Class I · High risk Terminated
Tydemy (drospirenone, ethinyl estradiol and levomefolate calcium tablets, 3 mg/0.03 mg/0.451 mg and levomefolate calcium tablets…
Reason Failed Stability Specification and Failed Impurities/Degradation Specifications: out of specification for inactive content ascorbic acid and…
Class II · Moderate risk Terminated
Safe Tussin PM Night Time Cough Relief (Cough Suppressant/Antihistamine), packaged in 4.0 FL OZ(118mL) bottles, Kramer…
Reason CGMP Deviations: use of non-food grade lubricant in mixing vessel.
Class II · Moderate risk Terminated
Safe Tussin DM Cough + Chest Congestion (Dextromethorphan HBr/ Cough Suppressant Guaifenesin/Expectorant), packaged in 4.0 FL…
Reason CGMP Deviations: use of non-food grade lubricant in mixing vessel.
Class II · Moderate risk Terminated
Tizanidine Tablets, USP, 4 mg, 100 Tablets (10 tablets x 10 unit dose blister packs) per carton, Rx Only, Packaged and…
Reason Failed Dissolution Specifications: this repackaged product was recalled by the manufacturer, Dr. Reddy's Laboratories, Inc., due to out of…
Class II · Moderate risk Terminated
Tramadol Hydrochloride Tablets, USP 50 mg, Unit Dose 100-Count Tablets Rx only, Manufactured by: Sun Pharmaceutical Industries…
Reason Packaging defect: blister packaging inadequately sealed.
Class II · Moderate risk Terminated
Endometrin (progesterone) Vaginal Insert 100mg, packaged in a carton of 21 vaginal inserts with 21 disposable vaginal…
Reason cGMP deviations: potential for Microbial Contamination of Non-Sterile Products
Class III · Low risk Terminated
Lysteda (tranexamic acid) USP Tablets, 650 mg, 30 tablets per bottle, Rx Only, Manufactured for: Amring Pharmaceuticals Inc…
Reason Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Class III · Low risk Terminated
GLYCOPYRROLATE INJECTION, USP 0.2MG/ML, 1mL VIAL, manufactured by HF Acquisition Co. LLC, Mukilteo, WA 98275, NDC 51662-1487-3
Reason Labeling: Label Mix-up
Class II · Moderate risk Terminated
StellaLife VEGA Oral Care Gel, 1 fl oz (30 ml) tubes, Peppermint, Distributed by: StellaLife, Inc., Aventura, FL NDC 69685-112-01
Reason cGMP deviations
Class II · Moderate risk Terminated
StellaLife VEGA Oral Care Gel, 1 fl oz (30 ml) tubes, Distributed by: StellaLife, Inc., Aventura, FL NDC 69685-102-02
Reason cGMP deviations
Class II · Moderate risk Terminated
StellaLife VEGA Oral Care Spray, 1 fl oz (30 ml) bottles, Distributed by: StellaLife, Inc., Aventura, FL NDC 69685-101-02
Reason cGMP deviations
Class II · Moderate risk Terminated
StellaLife VEGA Oral Care Rinse, 16 fl oz (473 ml) bottles, Coconut, Distributed by: StellaLife, Aventura, FL NDC 69685-113-16
Reason cGMP deviations
Class II · Moderate risk Terminated
StellaLife VEGA Oral Care Rinse, 16 fl oz (473 ml) bottles, Peppermint, Distributed by: StellaLife, Inc., Aventura, FL NDC…
Reason cGMP deviations
Class II · Moderate risk Terminated
SnoreStop Naso Spray Bulk, liquid, Distributed by Green Pharma, NDC 61152-199-99
Reason cGMP deviations
Class II · Moderate risk Terminated
DoloEar Earache Drops, 0.50 fl. oz. bottles, Distributed by Pharmadel LLC, Georgetown, DE NDC 55758-001-15
Reason cGMP deviations
Class II · Moderate risk Terminated
Babelyn Diarrhea Drops Homeopathic Remedy, 0.5 fl. oz. (15 mL) bottles, Distributed by Pharmadel LLC, Georgetown, DE NDC…
Reason cGMP deviations