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20,197 catalysts · 4,728 grant · 3,126 8k filing · 3,112 device 510k · 2,793 approval · 2,000 device pma · 2,000 device recall
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20,197 catalysts · 4,728 grant · 3,126 8k filing · 3,112 device 510k · 2,793 approval · 2,000 device pma · 2,000 device recall
Polyvinyl Alcohol Ophthalmic Solution 1.4%, Lubricant Eye Drops, Moisturizing, Sterile, 0.5 FL OZ (15mL) per dropper bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-678-15. — Reason: cGMP deviations and lack of assurance of sterility. — Status: Ongoing
TESTOSTERONE PELLET 200 mg (with Cholesterol </=4%), 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office Use Only, Belmar Select Outsources, 12860 W. Cedar Drive #211, Lakewood, CO 80228, NDC: 70168-0122-01 — Reason: Presence of Particulate Matter: Glass particles were found in pellet vials. — Status: Ongoing
Lubricant Eye Drops Solution, Polyethylene Glycol 400 0.4% Eye Lubricant, Propylene Glycol 0.3% Eye Lubricant, Lubricant Eye Drops, Moisturizing, Sterile, 0.5 FL OZ (15mL) per dropper bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-126-15. — Reason: cGMP deviations and lack of assurance of sterility. — Status: Ongoing
TESTOSTERONE PELLET 200 mg BLUNT (with Cholesterol </=2%), 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office Use Only, Belmar Select Outsources, 12860 W. Cedar Drive #211, Lakewood, CO 80228, NDC: 70168-0124-01 — Reason: Presence of Particulate Matter: Glass particles were found in pellet vials. — Status: Ongoing
Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Carboxymethlycellulose Sodium 0.5% Eye Lubricant, Lubricating Eye Drops, Moisturizing, Sterile, 0.5 FL OZ (15mL) per dropper bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-068-15. — Reason: cGMP deviations and lack of assurance of sterility. — Status: Ongoing
TESTOSTERONE PELLET 200 mg (with Cholesterol </=2%), 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office Use Only, Belmar Select Outsources, 12860 W. Cedar Drive #211, Lakewood, CO 80228, NDC: 70168-0125-01 — Reason: Presence of Particulate Matter: Glass particles were found in pellet vials. — Status: Ongoing
Product code: QGT. Advisory committee: Neurology. Type: Traditional
Product code: FAD. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: JDR. Advisory committee: Orthopedic. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Special
Product code: QKQ. Advisory committee: Pathology. Type: Traditional
Product code: INI. Advisory committee: Physical Medicine. Type: Traditional
Product code: GXQ. Advisory committee: Neurology. Type: Traditional
Product code: DZE. Advisory committee: Dental. Type: Traditional
Product code: QRL. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: GDW. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: MYN. Advisory committee: Radiology. Type: Traditional
Product code: QEW. Advisory committee: Cardiovascular. Type: Special
Sponsor: JANSSEN PHARMS. Form: SPRAY. Route: NASAL
Sponsor: INCYTE CORP. Form: INJECTABLE. Route: INTRAVENOUS
Product code: KDI. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: GXI. Advisory committee: Neurology. Type: Traditional
Product code: LDF. Advisory committee: Cardiovascular. Type: Special
Product code: QHH. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: QAQ. Advisory committee: Cardiovascular. Type: Traditional
Product code: OKO. Advisory committee: General, Plastic Surgery. Type: Special
Product code: NGX. Advisory committee: Physical Medicine. Type: Traditional
Product code: FDF. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: KOC. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: KOC. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: KRD. Advisory committee: Cardiovascular. Type: Traditional
Product code: MNT. Advisory committee: Anesthesiology. Type: Traditional
Product code: JTN. Advisory committee: Microbiology. Type: Traditional
Product code: IYN. Advisory committee: Radiology. Type: Traditional
Product code: LZO. Advisory committee: Orthopedic. Type: Traditional
Product code: IYN. Advisory committee: Radiology. Type: Traditional
Product code: SBF. Advisory committee: Neurology. Type: Traditional
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: FOZ. Advisory committee: General Hospital. Type: Traditional
Product code: DRG. Advisory committee: Cardiovascular. Type: Traditional
Product code: OWB. Advisory committee: Radiology. Type: Traditional
Product code: NDY. Advisory committee: Clinical Chemistry. Type: Traditional
Product code: JAK. Advisory committee: Radiology. Type: Traditional
Product code: SET. Advisory committee: Immunology. Type: Traditional
Product code: JAK. Advisory committee: Radiology. Type: Traditional
Product code: FKX. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: LZO. Advisory committee: Orthopedic. Type: Traditional