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27,004 catalysts · 17,239 approval · 3,880 device 510k · 2,448 grant · 1,398 device recall · 1,179 device pma · 860 recall
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27,004 catalysts · 17,239 approval · 3,880 device 510k · 2,448 grant · 1,398 device recall · 1,179 device pma · 860 recall
Kit for the Preparation of Technetium Tc 99m Sestamibi Injection, Each Kit contains: 30 sterile and non-pyrogenic reaction vials each containing Tetrakis (2-methoxy isobutyl isonitrile) Copper (I) tetratluoroborate - 1 mg; Stannous Chloride Dihydrate - 0.D75 mg; L-Cysteine Hydrochloride Monohydrate - 1 mg; Sodium Citrate Dihydrate - 2.6 mg; Mannitol - 20 mg. The pH is adjusted to 5.6 to 5.7 with HCI or NaOH prior to lyophilization. Sealed under nitrogen. 30 Radioassay Information Labels with radiation warning symbol. 1 package insert, Rx only, Manufacture by: Curium US LLC, Maryland Heights, MO 63043, 69945-092-40 — Reason: Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product — Status: Terminated
Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, 90 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-414-05 — Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit. — Status: Ongoing
Duloxetine Delayed-Release Capsules USP, 30 mg, Rx only, 30 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-414-04 — Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit. — Status: Ongoing
Duloxetine Delayed-Release Capsules, 60 mg, a) 30 count blister cards (NDC 70518-0937-04), b) 30 count bottles (NDC 70518-0937-03), Rx only, Source NDC 57237-0019-99, MFG: Rising Pharma, Inc., Allendale, NJ, Repackaged by: RemedyRepack Inc., Indiana, PA — Reason: CGMP Deviations; presence of N-nitroso-duloxetine impurity above recommended interim limit. — Status: Ongoing
Duloxetine Delayed-Release Capsules USP, 60 mg, Rx only, 30 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-415-04 — Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit. — Status: Ongoing
chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ; Product of India, NDC 68462-862-01 — Reason: CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit. — Status: Ongoing
DULoxetine DR USP, 30 mg, 90-count bottle, Rx Only, Packaged by: PD Rx Pharmaceuticals Inc, Oklahoma City, OK 73127, NDC: 43063-877-90 — Reason: CGMP Deviations: the presence of a Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Duloxetine above the interim acceptable intake limit — Status: Terminated
UMARY ACID HYALURONIC, 850 MG CAPLETS, 30-count bottle, UPC7502265120323 — Reason: cGMP Deviations: the firm initiated a recall after notification from the distributor that product may be tainted with undeclared diclofenac and omeprazole, however there is no analytical data confirming that product distributed by the firm is tainted. — Status: Ongoing
Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx Only, 90-count bottles (NDC 51991-748-90) Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. — Reason: CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. — Status: Ongoing
Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-415-08 — Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit. — Status: Ongoing
Product code: PKL. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: LBH. Advisory committee: Dental. Type: Traditional
Product code: GXY. Advisory committee: Neurology. Type: Traditional
Product code: QJP. Advisory committee: Cardiovascular. Type: Special
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: DQA. Advisory committee: Cardiovascular. Type: Traditional
Product code: OHS. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: ITI. Advisory committee: Physical Medicine. Type: Traditional
Sponsor: AGIOS PHARMS INC. Form: TABLET. Route: ORAL
Product code: FDF. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: DZL. Advisory committee: Dental. Type: Traditional
Product code: KPR. Advisory committee: Radiology. Type: Traditional
Product code: JAK. Advisory committee: Radiology. Type: Traditional
Product code: MMI. Advisory committee: Clinical Chemistry. Type: Traditional
Product code: GWN. Advisory committee: Neurology. Type: Traditional
Product code: MRN. Advisory committee: Anesthesiology. Type: Special
Product code: NHA. Advisory committee: Dental. Type: Traditional
Product code: OLR. Advisory committee: Unknown. Type: Traditional
Product code: DYH. Advisory committee: Dental. Type: Traditional
Product code: LLZ. Advisory committee: Radiology. Type: Traditional
Product code: QAS. Advisory committee: Radiology. Type: Traditional
Product code: DZE. Advisory committee: Dental. Type: Traditional
Product code: LZO. Advisory committee: Orthopedic. Type: Traditional
Product code: OLO. Advisory committee: Neurology. Type: Traditional
Product code: KPR. Advisory committee: Radiology. Type: Traditional
Product code: INI. Advisory committee: Physical Medicine. Type: Traditional
Product code: JAA. Advisory committee: Radiology. Type: Traditional
Product code: LLZ. Advisory committee: Radiology. Type: Traditional
Product code: INI. Advisory committee: Physical Medicine. Type: Traditional
Product code: KGN. Advisory committee: Unknown. Type: Traditional
Sponsor: ACTAVIS ELIZABETH. Form: CAPSULE. Route: ORAL
Sponsor: ACTAVIS ELIZABETH. Form: CAPSULE. Route: ORAL
Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION
Product code: JAK. Advisory committee: Radiology. Type: Traditional
Product code: LNH. Advisory committee: Radiology. Type: Traditional
Product code: KPR. Advisory committee: Radiology. Type: Traditional
Product code: NKB. Advisory committee: Orthopedic. Type: Traditional