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20,113 catalysts · 18,987 approval · 7,208 phase readout · 5,000 device 510k · 4,728 grant · 3,603 8k filing · 2,000 device pma
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20,113 catalysts · 18,987 approval · 7,208 phase readout · 5,000 device 510k · 4,728 grant · 3,603 8k filing · 2,000 device pma
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Sponsor: PF PRISM CV. Form: FOR SUSPENSION. Route: ORAL
Sponsor: OTSUKA PHARM CO LTD. Form: FOR SUSPENSION, EXTENDED RELEASE. Route: INTRAMUSCULAR
Sponsor: SAMSUNG BIOEPIS CO LTD. Form: INJECTION. Route: SOLUTION
Sponsor: AJANTA PHARMA LTD. Form: TABLET. Route: ORAL
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
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
Sponsor: AMNEAL PHARMS. Form: TABLET. Route: ORAL
Sponsor: AMNEAL PHARMS. Form: TABLET. Route: ORAL
Sponsor: NOVITIUM PHARMA. Form: TABLET. Route: ORAL
Sponsor: SCIENTURE. Form: SUSPENSION. Route: ORAL
Sponsor: FRESENIUS KABI USA. Form: INJECTABLE. Route: INTRAVENOUS
Sponsor: RHODES PHARMS. Form: TABLET. Route: ORAL
Sponsor: ALVOGEN. Form: TABLET. Route: ORAL
Sponsor: BROOKS STERISCIENCE. Form: INJECTABLE. Route: INJECTION
Sponsor: SAMSUNG BIOEPIS CO LTD. Form: INJECTABLE. Route: INJECTION
Sponsor: SAMSUNG BIOEPIS CO LTD. Form: INJECTABLE. Route: SUBCUTANEOUS
Sponsor: AUROBINDO PHARMA USA. Form: TABLET. Route: ORAL
Sponsor: EPIC PHARMA LLC. Form: CAPSULE. Route: ORAL
Sponsor: MICRO LABS. Form: TABLET. Route: ORAL
Sponsor: MYLAN PHARMS INC. Form: CAPSULE. Route: ORAL
Sponsor: ACCORD BIOPHARMA INC.. Form: INJECTABLE. Route: INTRAVENOUS
Sponsor: MERCK SHARP DOHME. Form: SOLUTION. Route: INTRAVENOUS
Sponsor: NOVARTIS. Form: SOLUTION. Route: ORAL
Sponsor: NOVARTIS. Form: CAPSULE. Route: ORAL
Sponsor: NOVARTIS. Form: TABLET. Route: ORAL
Sponsor: NOVARTIS. Form: CAPSULE. Route: ORAL
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
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
Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-746-05 — Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. — Status: Ongoing
Alprostadil Container Description: Amber color bottle — Reason: CGMP Deviations — Status: Ongoing
Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 1000-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-747-10 — Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. — Status: Ongoing
Sodium Chloride Injection 9%, USP, 500 mL, Single-Dose IV Bottle, Rx Only, nephron, 503B outsourcing facility, West Columbia, SC 29172, NDC: 69374-334-50 — Reason: Lack of Assurance of Sterility: There is a potential for leakage at the IV bottle port. — Status: Terminated
Bimatoprost NDC# 82187-1001-1 Container description: The product packed in double self-seal cover and finally packed in Aluminum cover for shipping. — Reason: CGMP Deviations — Status: Ongoing
PHENYLephrine added to 0.9% sodium chloride, 40 mg/250 mL* (160 mcg/mL), Rx Only, CAPS, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, 855-275-2270, NDC 71285-6092-1. — Reason: Presence of Particulate Matter — Status: Ongoing
Duloxetine Delayed-Release Capsules, USP, 60mg, Rx Only, 1000-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-748-10 — Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. — Status: Ongoing
Walgreens, Acne Control Cleanser, 10% Benzoyl Peroxide/Acne Treatment, NET WT 5 OZ (142g) Distributed by: Walgreen CO, 200 Wilmont RD, Deerfield, IL, Made in Canada. UPC#: 1 9560203602 8 — Reason: Chemical Contamination: Presence of benzene — Status: Ongoing
Latanoprost NDC# 82187-1002-1 Container Description: Amber colour bottle — Reason: CGMP Deviations — Status: Ongoing
POTASSIUM CHLORIDE Inj., 20 mEq total in 100 mL flexible container 24 x case, 200 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7075-26; Bar Code Flexible container (01) 00309907075266; Case (01)30309907075267 — Reason: Labeling: Label Error on Declared Strength. Cases labeled POTASSIUM CHLORIDE 20 mEq, may contain flexible containers with overwrap mislabeled as 10 mEq. The correct dosage strength of 20 mEq is printed on the labeling affixed to the product flexible container. — Status: Ongoing
Kids by babyganics SPF 50 totally tropical (titanium dioxide 3/5%, zinc oxide 7.25%) packaged in a) 6 OZ (170 g) spray bottles UPC 813277019954 and UPC 813277019800; and b) Twinpack UPC 813277019930; Dist. by KAS Direct LLC, 1525 Howe St. Racine, WI 53403. — Reason: Chemical Contamination — Status: Ongoing