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21,463 catalysts · 4,728 grant · 3,912 device 510k · 3,147 8k filing · 3,076 approval · 2,000 device pma · 2,000 device recall
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21,463 catalysts · 4,728 grant · 3,912 device 510k · 3,147 8k filing · 3,076 approval · 2,000 device pma · 2,000 device recall
Adrenalin Chloride Solution (Epinephrine Nasal Solution, USP), 30mg/30mL (1mg/mL), packaged in 30 mL vials, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 42023-103-01 — Reason: Labeling: Not Elsewhere Classified: misleading label similar in appearance to the FDA-approved drug product Adrenalin¿ (epinephrine injection, USP) — Status: Ongoing
HydrALAZINE Hydrochloride, 100 Tablets (10x10), USP, 50mg, Rx only, Manufactured by Strides Pharma Science Ltd, Bengaluru, India, Distributed by McKesson by: McKesson Corporation dba SKY Packaging, TN 38141. NDC 63739-328-10 — Reason: Failed Impurities/Degradation Specifications — Status: Ongoing
HydrALAZINE Hydrochloride, 25 mg, 100 Unit Dose Tablets (10x10), USP, Rx only, Manufactured by Strides Pharma Science Ltd, Bengaluru, India, Distributed by McKesson by: McKesson Corporation dba SKY Packaging, TN 38141. NDC 63739-327-10 — Reason: Failed Impurities/Degradation Specifications — Status: Ongoing
Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-514-05. — Reason: Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle. — Status: Ongoing
Product code: ITI. Advisory committee: Physical Medicine. Type: Special
Product code: LLZ. Advisory committee: Radiology. Type: Traditional
Product code: ITI. Advisory committee: Physical Medicine. Type: Special
Product code: DXO. Advisory committee: Cardiovascular. Type: Traditional
Product code: JAK. Advisory committee: Radiology. Type: Traditional
Product code: IYN. Advisory committee: Radiology. Type: Traditional
Product code: KLA. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: LNH. Advisory committee: Radiology. Type: Traditional
Product code: PPW. Advisory committee: Cardiovascular. Type: Traditional
Product code: MYF. Advisory committee: Microbiology. Type: Traditional
Product code: HSB. Advisory committee: Orthopedic. Type: Traditional
Sponsor: ASTRAZENECA. Form: TABLET. Route: ORAL
Sponsor: SAMSUNG BIOEPIS CO LTD. Form: INJECTABLE. Route: SUBCUTANEOUS
Product code: MBH. Advisory committee: Orthopedic. Type: Traditional
Product code: LCX. Advisory committee: Clinical Chemistry. Type: Traditional
Product code: PBF. Advisory committee: Orthopedic. Type: Traditional
Product code: KIF. Advisory committee: Dental. Type: Traditional
Product code: NRY. Advisory committee: Cardiovascular. Type: Traditional
Product code: QQX. Advisory committee: Microbiology. Type: Traditional
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: BSO. Advisory committee: Anesthesiology. Type: Traditional
Product code: OBP. Advisory committee: Neurology. Type: Traditional
Product code: ELC. Advisory committee: Dental. Type: Traditional
Product code: QZA. Advisory committee: General Hospital. Type: Special
Sponsor: DECIPHERA PHARMS. Form: CAPSULE. Route: ORAL
Sponsor: JANSSEN BIOTECH. Form: INJECTABLE. Route: INJECTION
Sponsor: ALVOTECH USA INC. Form: INJECTABLE. Route: INJECTION
Product code: QOF. Advisory committee: Microbiology. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Special
Product code: OHS. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: MMX. Advisory committee: Cardiovascular. Type: Special
Product code: QAS. Advisory committee: Radiology. Type: Special
Product code: NHA. Advisory committee: Dental. Type: Traditional
Product code: MRH. Advisory committee: General Hospital. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: MWI. Advisory committee: Cardiovascular. Type: Traditional
Product code: FLL. Advisory committee: General Hospital. Type: Traditional
Product code: POK. Advisory committee: Radiology. Type: Traditional
Product code: OAS. Advisory committee: Radiology. Type: Traditional
Product code: GWN. Advisory committee: Neurology. Type: Traditional
Product code: POM. Advisory committee: Neurology. Type: Traditional
Sponsor: ACCORD HLTHCARE. Form: SOLUTION. Route: INTRAVENOUS
Sponsor: PFIZER. Form: TABLET. Route: ORAL
Product code: QJP. Advisory committee: Cardiovascular. Type: Traditional