Class II · Moderate risk Ongoing
Nelarabine Injection, 250mg/50mL, (5mg/mL), packaged in: a) 50 mL Single-Dose Vial, NDC 70710-1839-1; b) 6 x 50 mL Single-Dose…
Reason Failed Impurities/Degradation Specifications
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Class II · Moderate risk Ongoing
Nelarabine Injection, 250mg/50mL, (5mg/mL), packaged in: a) 50 mL Single-Dose Vial, NDC 70710-1726-1; b) 6 x 50 mL Single-Dose…
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Ongoing
ViaMed Alcohol Prep Pads, For External Use Only, 70% Isopropyl Alcohol, Sterile, 100 pieces per Box, 100 boxes per Carton…
Reason Lack of assurance of sterility and cGMP deviations observed at the manufacturing site.
Class II · Moderate risk Terminated
Sodium Chloride Injection 9%, USP, 500 mL, Single-Dose IV Bottle, Rx Only, nephron, 503B outsourcing facility, West Columbia, SC…
Reason Lack of Assurance of Sterility: There is a potential for leakage at the IV bottle port.
Class II · Moderate risk Ongoing
Voriconazole Container Description: voriconazole The product packed in white poly bag containing black poly bag and tied each…
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Latanoprost NDC# 82187-1002-1 Container Description: Amber colour bottle
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Chlorambucil Container Description: The product packed in double self-seal cover and finally packed in Aluminum cover for…
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Finasteride NDC# 82187-1003-1 Container Description: The product packed in white poly bag containing black poly bag and tied…
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Alprostadil Container Description: Amber color bottle
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Bimatoprost NDC# 82187-1001-1 Container description: The product packed in double self-seal cover and finally packed in…
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Morphine Sulfate Extended-Release Tablets, 100 mg, 100-count bottles, Rx Only, Manufactured by: Ohm Laboratories Inc., New…
Reason Failed Dissolution Specifications
Class II · Moderate risk Completed
Estradiol Gel, 0.1%, 0.25 mg/g, 30 packets per carton, Rx Only, For Topical Use Only, Manufactured by Padagis, Yeruham, Israel…
Reason Defective Container: Some packets may not be fully sealed, potentially allowing for loss of Ethanol from the product.
Class II · Moderate risk Ongoing
Silodosin Capsules, 8mg, 90-count bottle, Rx only, Manufactured for: AvKare, Pulaski, TN 38478, Manufactured by: Amneal…
Reason Subpotent Drug: Out of Specification (OOS) result for De hydro Impurity (0.654%) for 18 M Stability sample and low assay 94.9% (specification of NLT…
Class II · Moderate risk Ongoing
CIPROFLOXACIN OPHTH SOLUTION, 0.3% 5mL bottle, Rx Only, Generic for CILOXAN, Packaged and Distributed by: DIRECT Rx, NDC…
Reason Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
Class I · High risk Ongoing
Fentanyl Transdermal System CII, 25mcg/h, packaged in a pouch, further packaged in 5-count carton, Rx only, Distributed by…
Reason Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.
Class II · Moderate risk Completed
fentaNYL Citrate In Sodium Chloride 1600mcg/100mL (16 mcg per mL) CII, Single use 100mL IV Bag, Fagron Sterile Services, 8710 E…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Potassium Chloride Extended-Release Tablets, USP, 10 mEq (750 mg), 100 Tablets per carton (10 x 10 unit dose blisters), Rx Only…
Reason Failed Dissolution Specifications.
Class II · Moderate risk Ongoing
Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141…
Reason CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II · Moderate risk Ongoing
Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141…
Reason CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II · Moderate risk Ongoing
Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141…
Reason CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II · Moderate risk Ongoing
Atomoxetine Capsules, USP, 40 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141…
Reason CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II · Moderate risk Ongoing
Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141…
Reason CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II · Moderate risk Ongoing
Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141…
Reason CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II · Moderate risk Ongoing
Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141…
Reason CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II · Moderate risk Ongoing
Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product…
Reason CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.