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21,407 catalysts · 4,728 grant · 3,890 device 510k · 3,126 8k filing · 3,063 approval · 2,000 device pma · 2,000 device recall
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21,407 catalysts · 4,728 grant · 3,890 device 510k · 3,126 8k filing · 3,063 approval · 2,000 device pma · 2,000 device recall
Product code: FGB. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: KWT. Advisory committee: Orthopedic. Type: Traditional
Sponsor: SANDOZ. Form: INJECTABLE. Route: INJECTION
Sponsor: SANDOZ. Form: INJECTABLE. Route: INJECTION
Sponsor: ASTELLAS. Form: SOLUTION. Route: INTRAVITREAL
Sponsor: PFIZER. Form: TABLET. Route: ORAL
Sponsor: ALVOTECH USA INC. Form: INJECTABLE. Route: INJECTION
Sponsor: NOVO NORDISK INC. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: SOMERSET THERAPS LLC. Form: SOLUTION. Route: INHALATION, ORAL
Carvedilol 25 mg Tablet, QTY: 30 Tablets per Blister Pack (3 x 10 blister cards), Rx Only, MFG by: Glenmark, Mahwah, NJ 07430, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC: 70518-3945-00. — Reason: CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended acceptable intake limit. — Status: Terminated
Guaifenesin and Codeine Phosphate Oral Solution USP, 100mg/10 mg per 5 mL, 16 fl oz (473 ml) bottles, PAI Pharmaceutical Associates, Inc., Greenville, SC 29605, NDC 0121-0775-16 — Reason: Superpotent; sodium benzoate preservative — Status: Completed
Carvedilol Tablets, USP, 12.5 mg, Rx only, a)500 Tablets, NDC 68462-164-05; b) 100 Tablets, NDC 68462-164-01, Manufactured for Glenmark Pharmaceuticals, NJ. — Reason: CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit. — Status: Ongoing
Carvedilol Tablets, USP, 25 mg, Rx only, a)500 Tablets, NDC 68462-165-05; b) 100 Tablets, NDC 68462-165-01, Manufactured for Glenmark Pharmaceuticals, NJ. — Reason: CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit. — Status: Ongoing
Potassium Chloride Extended-Release Tablets, USP, 10 mEq (750 mg), 100 Tablets per carton (10 x 10 unit dose blisters), Rx Only, Distributed by: Aurobindo Pharma USA< INC., 279 Princeton-Hightstown Road, East Windsor, NJ 08520. Made in India. Distributed by: MAJOR PHARMACEUTICALS, Livonia, MI 48152. NDC: 0904-7216-61 — Reason: Failed Dissolution Specifications. — Status: Ongoing
Granix (tbo-filgrastim) Injection 300 mcg/0.5 mL, Single Dose prefilled syringe, packaged as a) 1 syringe in 1 CARTON, NDC 63459-910-11, Blister NDC 63459-910-12; (b)10 syringes in 1 CARTON, NDC 63459-910-15, Blister NDC 63459-910-12; (c) 1 syringe in 1 CARTON, NDC 63459-910-17 without safety guard and blister, Rx Only, Manufactured by: UAB Teva Baltics, Vilnius, Lithuania. Distributed by Teva Pharmaceuticals USA, Inc. North Wales PA 19454. Product of Israel. — Reason: Failed Stability Specifications - 12-month stability test result for one of the known peptides is below the specification limit — Status: Ongoing
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