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14,388 catalysts · 3,350 8k filing · 2,435 grant · 2,379 approval · 1,691 device 510k · 1,229 device recall · 1,158 device pma
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14,388 catalysts · 3,350 8k filing · 2,435 grant · 2,379 approval · 1,691 device 510k · 1,229 device recall · 1,158 device pma
Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 90 Tablets per bottle, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-450-15. — Reason: Subpotent: During long term stability testing of Levothyroxine Sodium Tablets USP for 88 mcg, the assay content was observed below the approved specification range. — Status: Ongoing
Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL), 25 x 10 mL Multiple-Dose Vials, For Intravenous or Intramuscular use, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540. NDC: 43598-666-25 — Reason: Out-of-Specification (OOS) result during the 6-month stability testing; decreased preservative concentration. — Status: Ongoing
L-Arginine HCl for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. — Reason: Lack of Assurance of Sterility — Status: Ongoing
Low Solubility Peptide Reconstitution Solution for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.Also labeled as manufactured for CELIA Health. — Reason: Lack of Assurance of Sterility — Status: Ongoing
BPC-157/Thymosin Beta-4 for Injection, a) 10/10mg, b) 15/15mg, c) 15mg/15mg, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for CELIA Health, Extension Health and Medical Health Institute (MHI). — Reason: Lack of Assurance of Sterility — Status: Ongoing
Sermorelin Lyophilized powder for reconstitution, 10mg, Vial capacity 10 mL Multi-Dose, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. — Reason: Lack of Assurance of Sterility — Status: Ongoing
B6 (Pyridoxine HCl) for Injections, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Synergy Wellness — Reason: Lack of Assurance of Sterility — Status: Ongoing
Sterile Saline Reconstitution Solution for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. — Reason: Lack of Assurance of Sterility — Status: Ongoing
Semaglutide with B12 for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. — Reason: Lack of Assurance of Sterility — Status: Ongoing
Ultra Burn for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. — Reason: Lack of Assurance of Sterility — Status: Ongoing
Product code: FMF. Advisory committee: General Hospital. Type: Special
Product code: NHA. Advisory committee: Dental. Type: Special
Product code: HRX. Advisory committee: Orthopedic. Type: Traditional
Product code: MAI. Advisory committee: Orthopedic. Type: Special
Product code: GEH. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: QZZ. Advisory committee: Orthopedic. Type: Special
Product code: NEW. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: LLZ. Advisory committee: Radiology. Type: Traditional
Product code: JAK. Advisory committee: Radiology. Type: Traditional
Product code: NHA. Advisory committee: Dental. Type: Traditional
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: NZE. Advisory committee: Cardiovascular. Type: Traditional
Supplement type: 30-Day Notice. Product code: NPT. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LWQ. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LZP. Advisory committee: OP. Decision: OK30
Supplement type: Normal 180 Day Track No User Fee. Product code: PQP. Advisory committee: PA. Decision: APPR
Supplement type: 30-Day Notice. Product code: MIH. Advisory committee: CV. Decision: OK30
Sponsor: PF PRISM CV. Form: TABLET. Route: ORAL
Sponsor: PFIZER. Form: SOLUTION. Route: ORAL
Sponsor: ALVOTECH USA INC. Form: INJECTABLE. Route: INJECTION
Sponsor: ASCENDIS PHARMA BONE. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: REGCON HOLDINGS. Form: TABLET. Route: ORAL
Sponsor: AMGEN INC. Form: INJECTABLE. Route: INJECTION
Sponsor: BPI LABS. Form: INJECTABLE. Route: INJECTION
Sponsor: BOEHRINGER INGELHEIM. Form: INJECTABLE. Route: INJECTION
Sponsor: SANDOZ INC. Form: INJECTABLE. Route: INJECTION
Sponsor: IMMEDICA PHARMA. Form: SUSPENSION. Route: ORAL
Sponsor: IMMEDICA PHARMA. Form: SUSPENSION. Route: ORAL
Sponsor: COVIS. Form: SOLUTION. Route: INTRAVENOUS
Sponsor: PIRAMAL CRITICAL. Form: LIQUID. Route: INHALATION
Sponsor: CELLTRION. Form: INJECTABLE. Route: INJECTION
Product code: GEH. Advisory committee: General, Plastic Surgery. Type: Special
Product code: HHK. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: OHS. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: LLZ. Advisory committee: Radiology. Type: Special
Product code: FBK. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: FMI. Advisory committee: General Hospital. Type: Traditional
Product code: NHA. Advisory committee: Dental. Type: Traditional
Product code: GEH. Advisory committee: General, Plastic Surgery. Type: Special
Product code: QHH. Advisory committee: Gastroenterology, Urology. Type: Traditional