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1,132 catalysts · 18,987 approval · 5,000 device 510k · 4,728 grant · 4,207 phase readout · 2,234 8k filing · 2,000 device pma
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1,132 catalysts · 18,987 approval · 5,000 device 510k · 4,728 grant · 4,207 phase readout · 2,234 8k filing · 2,000 device pma
Carvedilol 25 mg Tablet, QTY: 30 Tablets per Blister Pack (3 x 10 blister cards), Rx Only, MFG by: Glenmark, Mahwah, NJ 07430, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC: 70518-3945-00. — Reason: CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended acceptable intake limit. — Status: Terminated
Guaifenesin and Codeine Phosphate Oral Solution USP, 100mg/10 mg per 5 mL, 16 fl oz (473 ml) bottles, PAI Pharmaceutical Associates, Inc., Greenville, SC 29605, NDC 0121-0775-16 — Reason: Superpotent; sodium benzoate preservative — Status: Completed
Carvedilol Tablets, USP, 12.5 mg, Rx only, a)500 Tablets, NDC 68462-164-05; b) 100 Tablets, NDC 68462-164-01, Manufactured for Glenmark Pharmaceuticals, NJ. — Reason: CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit. — Status: Ongoing
Carvedilol Tablets, USP, 25 mg, Rx only, a)500 Tablets, NDC 68462-165-05; b) 100 Tablets, NDC 68462-165-01, Manufactured for Glenmark Pharmaceuticals, NJ. — Reason: CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit. — Status: Ongoing
Potassium Chloride Extended-Release Tablets, USP, 10 mEq (750 mg), 100 Tablets per carton (10 x 10 unit dose blisters), Rx Only, Distributed by: Aurobindo Pharma USA< INC., 279 Princeton-Hightstown Road, East Windsor, NJ 08520. Made in India. Distributed by: MAJOR PHARMACEUTICALS, Livonia, MI 48152. NDC: 0904-7216-61 — Reason: Failed Dissolution Specifications. — Status: Ongoing
Granix (tbo-filgrastim) Injection 300 mcg/0.5 mL, Single Dose prefilled syringe, packaged as a) 1 syringe in 1 CARTON, NDC 63459-910-11, Blister NDC 63459-910-12; (b)10 syringes in 1 CARTON, NDC 63459-910-15, Blister NDC 63459-910-12; (c) 1 syringe in 1 CARTON, NDC 63459-910-17 without safety guard and blister, Rx Only, Manufactured by: UAB Teva Baltics, Vilnius, Lithuania. Distributed by Teva Pharmaceuticals USA, Inc. North Wales PA 19454. Product of Israel. — Reason: Failed Stability Specifications - 12-month stability test result for one of the known peptides is below the specification limit — Status: Ongoing
Adrenalin Chloride Solution (Epinephrine Nasal Solution, USP), 30mg/30mL (1mg/mL), packaged in 30 mL vials, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 42023-103-01 — Reason: Labeling: Not Elsewhere Classified: misleading label similar in appearance to the FDA-approved drug product Adrenalin¿ (epinephrine injection, USP) — Status: Ongoing
HydrALAZINE Hydrochloride, 100 Tablets (10x10), USP, 50mg, Rx only, Manufactured by Strides Pharma Science Ltd, Bengaluru, India, Distributed by McKesson by: McKesson Corporation dba SKY Packaging, TN 38141. NDC 63739-328-10 — Reason: Failed Impurities/Degradation Specifications — Status: Ongoing
HydrALAZINE Hydrochloride, 25 mg, 100 Unit Dose Tablets (10x10), USP, Rx only, Manufactured by Strides Pharma Science Ltd, Bengaluru, India, Distributed by McKesson by: McKesson Corporation dba SKY Packaging, TN 38141. NDC 63739-327-10 — Reason: Failed Impurities/Degradation Specifications — Status: Ongoing
Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-514-05. — 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. — Status: Ongoing
Irbesartan Tablets USP, 300 mg, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 50268-442-15 — Reason: Out of Specification for Dissolution — Status: Ongoing
Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-270-30. — Reason: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. — Status: Ongoing
Estradiol Gel, 0.1%, 0.25 mg/g, 30 packets per carton, Rx Only, For Topical Use Only, Manufactured by Padagis, Yeruham, Israel, NDC: 45802-0134-30 — Reason: Defective Container: Some packets may not be fully sealed, potentially allowing for loss of Ethanol from the product. — Status: Completed
Ergocalciferol - Vitamin D Supplement - 10 mcg (400 Units) per 0.05 mL Oral Syringe, Delivers: 0.05 mL Oral Solution, Mfg by: Westminster, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: 69367028302. — Reason: Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes. — Status: Ongoing
Unisom, SleepMelts, Diphenhydramine HCl tablets, 25 mg, Nighttime Sleep-Aid, 4 x 8 blister packs per carton, Cherry flavor, Manufactured by Adare Pharmaceuticals, Inc., Dist. by Chattem, Inc., P.O. Box 2219, Chattanooga, TN 37409, UPC # 0 41167 0014 0 — Reason: CGMP Deviations: Nitrosamine Drug Substance Related Issue impurity above the daily acceptable intake limit defined by the Food and Drug Administration. — Status: Ongoing
Lorazepam Tablets, USP, 0.5mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package is from NDC # 69315-904 Leading Pharma, LLC., Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 26268 USA, NDC: 0904-6007-61 — Reason: Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities. — Status: Ongoing
Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-269-30. — Reason: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. — Status: Ongoing
Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-756-01. — Reason: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. — Status: Ongoing
Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-761-01. — Reason: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. — Status: Ongoing
Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-265-30. — Reason: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. — Status: Ongoing
fentaNYL Citrate In Sodium Chloride 1600mcg/100mL (16 mcg per mL) CII, Single use 100mL IV Bag, Fagron Sterile Services, 8710 E 34th St N, Wichita, KS 67726 Bar Code 71266-5060-01 — Reason: Lack of Assurance of Sterility — Status: Completed
Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-757-01. — Reason: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. — Status: Ongoing
Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-266-30. — Reason: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. — Status: Ongoing
Fentanyl Transdermal System CII, 25mcg/h, packaged in a pouch, further packaged in 5-count carton, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058, Manufactured by: Kindeva Drug Delivery L/P, Northridge, CA 91324, NDC 47781-424-47. — Reason: Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch. — Status: Ongoing
Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-760-01. — Reason: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. — Status: Ongoing
Silodosin Capsules, 8mg, 90-count bottle, Rx only, Manufactured for: AvKare, Pulaski, TN 38478, Manufactured by: Amneal Pharmaceuticals of NY, LLC, NY 11719, NDC 42291-778-90 — 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 95.0% NMT 105%) — Status: Ongoing
Phenylephrine HCl Injection, USP 100 mg/10 mL (10 mg/mL) vials, Rx only, Pharmacy Bulk Package (supplied as a single unit), Dist. by: Provepharm, Inc., Collegeville, PA 19426 — Reason: Presence of Particulate Matter. — Status: Ongoing
Lorazepam Tablets, USP, 1mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package is from NDC # 69315-905 Leading Pharma, LLC., Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 26268 USA, NDC: 0904-6008-61. — Reason: Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities. — Status: Ongoing
Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-267-30. — Reason: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. — Status: Ongoing
Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-271-30. — Reason: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. — Status: Ongoing
Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-759-01. — Reason: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. — Status: Ongoing
Atomoxetine Capsules, USP, 40 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-268-30. — Reason: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. — Status: Ongoing
Lorazepam Tablets, USP, 2mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package is from NDC # 69315-906 Leading Pharma, LLC., Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 26268 USA, NDC: 0904-6009-61. — Reason: Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities. — Status: Ongoing
Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-755-01. — Reason: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. — Status: Ongoing
Atomoxetine Capsules, USP, 40 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-758-01. — Reason: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. — Status: Ongoing
Avastin 1.25 mg/0.05 mL in 0.25 mL Syringe, For Intravitreal Injection Only, Office Use Only - Not for Resale - Single Use, This drug product was repackaged by Turbare Manufacturing, 925 Jeanette Drive, Conway, AR 72032, NDC: 83556-0101-01. — Reason: Lack of Assurance of Sterility: due to a quality control process deviation. During an internal quality assurance review, an Acceptable Quality Limit (AQL) inspection was not conducted on a statistically sound number of samples. This may result in the inability to assure that the impacted products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess and may lead to products of unacceptable quality. — Status: Completed
ViaMed Alcohol Prep Pads, For External Use Only, 70% Isopropyl Alcohol, Sterile, 100 pieces per Box, 100 boxes per Carton, Sterile, Manufactured by Wuxi Medical Instrument Factory Co., Ltd., Made in China, Manufactured for: Rece International Corp., Miami Lakes, FL, 33014, USA, NDC: 70006-500-01. — Reason: Lack of assurance of sterility and cGMP deviations observed at the manufacturing site. — Status: Ongoing
Lorazepam 0.5 mg per 0.25 mL Oral Syringe, Delivers: 0.25 mL, Oral Concentrate, Rx Only, Refrigerate, Mfg by: PAI, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: a) 00054353244, b) 00121077001, c) 65162068784. — Reason: Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes. — Status: Ongoing
Ferrous Sulfate 7.5 mg Iron/0.5 mL Oral Syringe, Delivers: 0.5 mL, Iron Supplement Drops, Mfg by: Akron Pharma, Pkg by: Safecor, Columbus, OH 43204. NDC: a) 71399748005, b) 39328055750, c) 69618007059. — Reason: Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes. — Status: Ongoing
Morphine Sulfate Extended-Release Tablets, 100 mg, 100-count bottles, Rx Only, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901. Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512. NDC 63304-452-01 — Reason: Failed Dissolution Specifications — Status: 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 Vial, NDC 70710-1839-8, Rx only, Manufactured by Zydus Lifesciences Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc, Pennington, NJ — Reason: Failed Impurities/Degradation Specifications — Status: Ongoing
Morphine Sulfate 5 mg per 0.25 mL Oral Syringe, Delivers: 0.25 mL, Oral Solution, Rx Only, Mfg by: Hikma, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: a) 00406800312, b) 00406800330, c) 00054051750. — Reason: Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes. — Status: Ongoing
Simethicone 20 mg per 0.3 mL Oral Syringe, Delivers: 0.3 mL, Oral Drops, Mfg By: Rugby, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: 00536130375. — Reason: Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes. — Status: 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 Vial, NDC 70710-1726-8, Rx only, Manufactured by Zydus Lifesciences Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc, Pennington, NJ — Reason: Failed Impurities/Degradation Specifications — Status: Ongoing
Chlorambucil Container Description: The product packed in double self-seal cover and finally packed in Aluminum cover for shipping. — Reason: CGMP Deviations — Status: Ongoing
Finasteride NDC# 82187-1003-1 Container Description: The product packed in white poly bag containing black poly bag and tied each individual finally packed in HDPE container for shipping. — Reason: CGMP Deviations — Status: Ongoing
Livalo (pitavatstatin) tablets, 4 mg, 90-count bottles, Rx only, Manufactured by: Patheon, Inc. Cincinnati, OH 45237 USA or by Kowa Company, Ltd, Nagoya, 462-0024 Japan, Marketed by Kowa Pharmaceuticals: Kowa Pharmaceuticals America Inc., Montgomery, AL 36117 USA NDC 66869-404-90 HDPE Bottle, congregated into a shrink wrapped 6-pack further congregated into 24 6-packs in a cardboard case — Reason: Presence of foreign tablets/capsules — Status: Completed
Zapzyt, Acne Treatment Gel, 10% benzoyl peroxide Gel, packaged in 1 oz (28.35g) tube, Distributed by: FOCUS CONSUMER HEALTHCARE, LLC., 801 Broad St Ste 200, Chattanooga, TN 37402. NDC 71687-0011-1 — Reason: Chemical Contamination: Presence of benzene. — Status: Ongoing
Kids by babyganics SPF 50 mineral sunscreen totally tropical (titanium dioxide 3/5%, zinc oxide 7.25%), packaged in 3 OZ spray bottles, Dist. by KAS Direct LLC, 1525 Howe St. Racine, WI 53403, UPC 813277019923 and UPC 813277019916 — Reason: Chemical Contamination — Status: Ongoing
POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL, 100 mEq/L flexible container, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7074-26; Bar Code (01)00309907074269 — Reason: Labeling: Label Error on Declared Strength. Overwrap labeled as Potassium Chloride Inj 10 mEq may contain flexible containers of Potassium Chloride Inj 20 mEq — Status: Ongoing