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23,505 catalysts · 5,000 device 510k · 4,728 grant · 3,778 approval · 3,208 8k filing · 2,000 device pma · 2,000 device recall
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23,505 catalysts · 5,000 device 510k · 4,728 grant · 3,778 approval · 3,208 8k filing · 2,000 device pma · 2,000 device recall
Ramipril Capsules USP 2.5 mg, a) 90 count (NDC 68180-589-09), b) 100 count NDC 68180-589-01), and c) 500 count (NDC 68180-589-02) bottles, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured by Lupin Limited, Goa, India — Reason: CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor — Status: Terminated
Ramipril Capsules USP 5 mg, a) 90 count (NDC 68180-590-09), b) 100 count NDC 68180-590-01), and c) 500 count (NDC 68180-590-02) bottles, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured by Lupin Limited, Goa, India — Reason: CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor — Status: Terminated
Docusate Sodium 250 mg, 1 Softgel in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-101-01 — Reason: cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity. — Status: Ongoing
Xelstrym (dextroamphetamine) transdermal system, 13.5 mg dextroamphetamine/9 hours, 30 individually sealed transdermal patches, inside a foil-sealed polypropylene tray, packed in a paper carton/box, MANUFACTURED BY NOVEN PHARMACEUTICALS, INC., Miami, FL 33186 United Sates, NDC 68968-0215-3 — Reason: Defective Delivery System: The product does not meet predetermined specifications for Coldflow (adhesive). — Status: Ongoing
Lisinopril Tablets, USP 10 mg, 90 tablets per bottle, Rx Only, Distributed by: Walmart, Bentonville, AR 72716, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045, NDC# 68645-610-90. — Reason: Presence of Foreign Object: A pharmacist discovered a metal fragment embedded in a lisinopril 10 mg tablet. — Status: Completed
Vitamin B1, 100 mcg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-108-01 — Reason: cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity. — Status: Ongoing
Vitamin D3, 25 mcg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-104-01 — Reason: cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity. — Status: Ongoing
Product code: QAU. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: QJY. Advisory committee: General Hospital. Type: Special
Product code: PGY. Advisory committee: Radiology. Type: Abbreviated
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: IYN. Advisory committee: Radiology. Type: Traditional
Product code: KPI. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: OHS. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: OHT. Advisory committee: General, Plastic Surgery. Type: Special
Product code: FBO. Advisory committee: Gastroenterology, Urology. Type: Special
Product code: HTN. Advisory committee: Orthopedic. Type: Special
Product code: JFB. Advisory committee: Physical Medicine. Type: Special
Product code: EBF. Advisory committee: Dental. Type: Traditional
Product code: QPB. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: OHS. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: PTI. Advisory committee: General Hospital. Type: Traditional
Product code: FOZ. Advisory committee: General Hospital. Type: Traditional
Product code: OWW. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: ITI. Advisory committee: Physical Medicine. Type: Traditional
Sponsor: BIOCON BIOLOGICS INC. Form: INJECTABLE. Route: INJECTION
Sponsor: NOVEN PHARMS INC. Form: FILM, EXTENDED RELEASE. Route: TRANSDERMAL
Sponsor: NOVEN PHARMS INC. Form: SYSTEM. Route: TRANSDERMAL
Product code: NLH. Advisory committee: Cardiovascular. Type: Traditional
Product code: DQA. Advisory committee: Cardiovascular. Type: Traditional
Product code: QWL. Advisory committee: Orthopedic. Type: Special
Product code: POV. Advisory committee: Hematology. Type: Traditional
Sponsor: JANSSEN BIOTECH. Form: INJECTABLE. Route: INJECTION
Sponsor: JANSSEN BIOTECH. Form: INJECTABLE. Route: INJECTION
Sponsor: AVYXA HOLDINGS. Form: POWDER. Route: INTRAVENOUS
Product code: CBK. Advisory committee: Anesthesiology. Type: Traditional
Product code: JCX. Advisory committee: General, Plastic Surgery. Type: Special
Product code: PSY. Advisory committee: Pathology. Type: Traditional
Product code: KZH. Advisory committee: General Hospital. Type: Traditional
Product code: OAP. Advisory committee: Physical Medicine. Type: Traditional
Product code: FEB. Advisory committee: Gastroenterology, Urology. Type: Special
Product code: HRX. Advisory committee: Orthopedic. Type: Traditional
Product code: HSN. Advisory committee: Orthopedic. Type: Traditional
Sponsor: PF PRISM CV. Form: TABLET. Route: ORAL
Sponsor: PF PRISM CV. Form: CAPSULE. Route: ORAL
Sponsor: REMPEX. Form: POWDER. Route: INTRAVENOUS
Sponsor: FRESENIUS KABI USA. Form: INJECTABLE. Route: INTRAVENOUS
Product code: KTT. Advisory committee: Orthopedic. Type: Traditional
Product code: MAI. Advisory committee: Orthopedic. Type: Special
Product code: JAK. Advisory committee: Radiology. Type: Traditional