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18,294 catalysts · 4,728 grant · 3,126 8k filing · 2,643 approval · 2,206 device 510k · 1,789 device recall · 1,544 device pma
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18,294 catalysts · 4,728 grant · 3,126 8k filing · 2,643 approval · 2,206 device 510k · 1,789 device recall · 1,544 device pma
Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg, 100 Capsules bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL, 34108, United States, Manufactured by: Lupin Limited, Goa 103 722, INDIA, NDC 68180-755-01. — Reason: Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027 — 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: spike of the cap becomes lodged in the nozzle of the product bottle. — Status: Ongoing
Sucralfate Tablets, USP 1 gram, packaged in a) 100-count bottles NDC 29033-0003-01, and b) 500-count bottles, NDC 29033-0003-05), Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas City, MO 64120. — Reason: CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated. — Status: Ongoing
Bicillin L-A (penicllin G benzathine injectable suspension), 1,200,000 units per 2 mL, 2 mL-vial, Rx Only, Distributed by Pfizer Inc., New York, NY 10001. Made in Austria, Carton NDC - 60793-701-10, Syringe NDC - 60793-701-02 — Reason: CGMP Deviations; particulates identified during visual inspection — Status: Ongoing
Lorazepam Injection, USP, 2 mg/mL, 25 x 1mL vials/carton, Rx Only, Manufactured by: Hikma Berkeley Heights, NJ 07922, NDC# 0641-6044-25 — Reason: Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds — Status: Ongoing
Bicillin L-A (penicillin G benzathine injectable suspension), 2,400,000 units per 4 mL, 4ml-vial, Rx Only, Distributed by Pfizer Inc., New York, NY 10001, Made in Austria, Carton NDC- 60793-702-10 , Syringe NDC-60793-702-04 — Reason: CGMP Deviations; particulates identified during visual inspection — Status: Ongoing
Cinacalcet Tablets 90 mg, 30-count bottles, Rx only, Manufactured by: Strides Pharma Science Ltd. Puducherry, India; Distributed by: Strides Pharma Inc. East Brunswick, NJ 08816, NDC 64380-885-04 — Reason: Failed Dissolution Specifications. — Status: Ongoing
Supplement type: 30-Day Notice. Product code: QON. Advisory committee: GU. Decision: OK30
Supplement type: 30-Day Notice. Product code: LWP. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: EZW. Advisory committee: GU. Decision: OK30
Supplement type: 135 Review Track For 30-Day Notice. Product code: FTR. Advisory committee: SU. Decision: APPR
Supplement type: 30-Day Notice. Product code: MHY. Advisory committee: NE. Decision: OK30
Supplement type: 30-Day Notice. Product code: LGW. Advisory committee: NE. Decision: OK30
Product code: SFI. Advisory committee: CH. Decision: APPR
Supplement type: 30-Day Notice. Product code: MCM. Advisory committee: EN. Decision: OK30
Supplement type: 30-Day Notice. Product code: NVZ. Advisory committee: CV. Decision: OK30
DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12110 LV VENT 10FR, Model Number 12110 — Reason: The catheters may not retain their shape. — Status: Ongoing
Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included. 50mL, Product Code 21-7001-24 — Reason: Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter. — Status: Ongoing
Vasoview Hemopro 3 Endoscopic Vessel Harvesting System Model No. C-VH-6000. The VASOVIEW HEMOPRO 3 Endoscopic Vessel Harvesting (EVH) System (VH-6000, VH-6001, and VH-6010) is a vessel harvesting kit designed for use with a 7 mm endoscope to cut and cauterize vessel branches. The HP3 Harvesting Tool features two curved, insulated jaws with heating elements that operate through heat and pressure rather than radiofrequency energy. — Reason: Reports of out-of-box failures discovered during the limited launch phase. Failure modes included angled deformity at the attachment site of the Harvesting Tool Jaws and the distal end of the Harvesting Tool Shaft, jaws not fully closed out of box, and heater wire lifted/flexed away from jaws. — Status: Ongoing
Smiths Medical CADD Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included. 100mL, Product Code 21-7302-24 — Reason: Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter. — Status: Ongoing
Smiths Medical NRFit CADD Yellow Medication Cassette Reservoir with NRFit connector with flow stop, yellow-striped tubing, clamp and female NRFit connector. Yellow stopper included 100mL", Product Code 21-7600-24 — Reason: Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter. — Status: Ongoing
ViziShot 2FLEX. Single Use Aspiration Needle. Model Number: NA-U403SX-4019. The ViziShot 2 FLEX tissue biopsy device is made up of four main parts: a handle, a sheath, a needle, and a stylet. The sheath and needle are attached to the handle, and the stylet, which is removable, is located inside the needle tube. — Reason: Potential for undetected, deformed a-traumatic tips. — Status: Ongoing
Reef TA Inserter, Part Number: TA2-001003, part of the Reef Interbody System — Reason: Inserter, used as part of a system with an intervertebral body fusion device, may contribute to difficulty disengaging the implant or improper implant positioning, which may may lead to prolonged surgery, intraoperative revision, and may require the use of alternate instrumentation. Devices may also have incorrect UDI-DI marking. — Status: Ongoing
Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Non-vented stopper included. 100mL, Product Code 21-7002-24 — Reason: Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter. — Status: Ongoing
DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12115 LV VENT 15FR, Model Number 12115 — Reason: The catheters may not retain their shape. — Status: Ongoing
Smiths Medical CADD" Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included. 50mL, Product Code 21-7301-24 — Reason: Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter. — Status: Ongoing
Xpert SA Nasal Complete Catalog Number: GXSACOMP-10 UDI-DI code: 07332940000158 Xpert SA Nasal Complete kit; 10 test kit: A collection of reagents and other associated materials intended to be used for the direct qualitative and/or quantitative detection of nucleic acid from methicillin-resistant and methicillin-susceptible Staphylococcus aureus (MRSA/MSSA) bacteria present in a clinical specimen, using a nucleic acid technique — Reason: As a result of Post-Market half-time stability testing, false negative test result was observed for a positive sample type. — Status: Ongoing
Smiths Medical CADD" Yellow Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included 100mL, Product Code 21-7300-24 — Reason: Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter. — Status: Ongoing
DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12113 LV VENT 13FR, Model Number 12113 — Reason: The catheters may not retain their shape. — Status: Ongoing
Product code: GCJ. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: KWL. Advisory committee: Orthopedic. Type: Special
Product code: DPS. Advisory committee: Cardiovascular. Type: Traditional
Product code: JXG. Advisory committee: Neurology. Type: Traditional
Product code: GCJ. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: LLZ. Advisory committee: Radiology. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: MBI. Advisory committee: Orthopedic. Type: Traditional
Product code: FPA. Advisory committee: General Hospital. Type: Abbreviated
Product code: LNH. Advisory committee: Radiology. Type: Traditional
Product code: DXN. Advisory committee: Cardiovascular. Type: Traditional
Sponsor: ZYDUS LIFESCIENCES. Form: TABLET. Route: ORAL
Supplement type: 30-Day Notice. Product code: PQP. Advisory committee: PA. Decision: OK30
Supplement type: 30-Day Notice. Product code: MAQ. Advisory committee: MI. Decision: OK30
Supplement type: 30-Day Notice. Product code: NRA. Advisory committee: OR. Decision: OK30
Supplement type: 30-Day Notice. Product code: MGB. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: MKT. Advisory committee: MI. Decision: OK30
Supplement type: Normal 180 Day Track. Product code: NRA. Advisory committee: OR. Decision: APPR
Supplement type: 30-Day Notice. Product code: MIH. Advisory committee: CV. Decision: OK30
Supplement type: Real-Time Process. Product code: OAE. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: QZI. Advisory committee: CV. Decision: OK30