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5,272 catalysts · 4,728 grant · 3,603 8k filing · 2,594 approval · 1,952 device 510k · 1,578 device recall · 1,359 device pma
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5,272 catalysts · 4,728 grant · 3,603 8k filing · 2,594 approval · 1,952 device 510k · 1,578 device recall · 1,359 device pma
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Good Neighbor Pharmacy, Alcohol Prep Pads, Distributed By AmeriSource Bergen, 1 West First Avenue, Conshohocken, PA 19428, Made in China: 100 eaches per box, 30 boxes per case, (3,000 eaches per case), NDC 46122-043-78. — Reason: Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. — Status: Ongoing
CURAD Alcohol Prep Pads, Sterile, Medium, 2-Ply, Contents: 5 boxes per Carton, 30 Boxes per Case, Single Use Only, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093, USA, Made in India, www.curad.com, 1-800-633-5463, NDC 53329-827-30 — Reason: Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. — Status: Ongoing
Enoxaparin Sodium Injection, USP, 30 mg/0.3 mL, packaged in 0.3 mL prefilled syringes further packaged in bags of 5 prefilled syringes, Rx Only, Dist. by: Sandoz Inc., Princeton, NJ 08540, Outer package - NDC 55154-3543-5, Inner label - NDC 0781-3238-01 — Reason: Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL — Status: Ongoing
ReliOn, Sterile Alcohol Swabs, Skin Cleanser, 200 Swabs, Distributed by, Walmart, Inc., Bentonville, AR 72716 Walmart: 200 eaches per box, 24 boxes per case (4,800 eaches per case), NDC 49035-814-60. — Reason: Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. — Status: Ongoing
Acetaminophen Injection 1000 mg/100 mL (10 mg/mL), packaged in 100 mL Viaflo container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Made in Ireland, NDC 36000-306-60. — Reason: Discoloration — Status: Ongoing
Medline Alcohol Prep Pads, 70% Isopropyl Alcohol, 100 Sterile 2-Ply Pads, Single Use Only, Large, www.medline.com, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093 USA, 1-800-MEDLINE, NDC 53329-811-30. — Reason: Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. — Status: Ongoing
Lisdexamfetamine Dimesylate Capsules, 40 mg, 100-count bottles, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC 0527-4664-37 — Reason: Labeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate Capsules 40mg, contained Lisdexamphetamine Dimesylate Capsules 30mg. — Status: Completed
Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217 NDC 60687-695-01 - Carton NDC [60687-695-11- Unit Dose] — Reason: CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated. — Status: Ongoing
RITE AID PHARMACY, first aid alcohol prep pads, DISTRIBUTED BY: RITE AID. 200 NEWBERRY COMMONS, ETTERS, PA 17319, NDC 11822-5156-2. — Reason: Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. — Status: Ongoing
H-E-B, inControl, Sterile* Alcohol Pads, CONT. 100 PADS, Packaged in China with components from Taiwan, Elaborado Con Orgullo Y Cuidado PARA H-E-B, San Antonio, TX 78204, NDC 37808-809-09. — Reason: Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. — Status: Ongoing
AT grant. $306,872. PI: Chase Madison Clark
HL grant. $320,838. PI: WILLIAM A SMITH
AR grant. $366,639. PI: Christina Charles-Schoeman
AR grant. $646,506. PI: Zhiliang Cheng
HD grant. $787,154. PI: Sabra L. Katz-Wise
HD grant. $236,547. PI: Hui-Ju Young
HL grant. $647,573. PI: James Even Voss
CA grant. $425,304. PI: Hao Zhu
NR grant. $52,538. PI: Lauren Anne Fisher
GM grant. $501,000. PI: James M Holton
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HL grant. $694,466. PI: HARPREET SINGH
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HL grant. $1,074,576. PI: GUOSHUN WANG
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HL grant. $516,986. PI: Paula M Cannon