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12,031 catalysts · 3,350 8k filing · 2,283 grant · 1,778 approval · 1,169 device 510k · 1,000 device adverse event · 849 device pma
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12,031 catalysts · 3,350 8k filing · 2,283 grant · 1,778 approval · 1,169 device 510k · 1,000 device adverse event · 849 device pma
Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton, Rx Only, Manufactured by: Invagen Pharmaceuticals, Inc., Hauppauge, NY 11786, Manufactured for : Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-936-98. — Reason: Failed stability specifications: Out of specification for hardness test — Status: Ongoing
Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-908-56 — Reason: Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit. — Status: Ongoing
Morphine Sulfate Oral Solution 100 mg / 5 mL (20 mg* / mL), 30 mL, Rx Only, For Oral Use Only, Manufactured By: /winder Laboratories, LLC, Winder, GA 30680. NDC: 75826-131-01 — Reason: Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton. — Status: Ongoing
Ganirelix Acetate Injection, 250 mcg/0.5mL, Single-dose Sterile Prefilled Syringe, 27 gauge by 1/2' needle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, United States, Manufactured by: Lupin Limited, Nagpur - 441108, INDIA, NDC 70748-274-01 — Reason: Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity. — Status: Ongoing
Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc., Naples, FL 34108, NDC 68180-353-09. — Reason: Defective container - seal not adhering to bottles — Status: Ongoing
Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-412-02 — Reason: CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits. — Status: Ongoing
Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-410-02 — Reason: CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits. — Status: Ongoing
Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton, Rx Only, Manufactured by: Invagen Pharmaceuticals, Inc., (a subsidary of Cipla Ltd) Hauppauge, NY 11786, Manufactured for: Exelan Pharmaceuticals, Inc., Boca Raton, FL 33422, Carton NDC 76282-478-90; Bottle NDC 76282-478-13. — Reason: Failed stability specifications: Out of specification for hardness test — Status: Ongoing
Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-411-02 — Reason: CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits. — Status: Ongoing
Nebivolol Tablets, 20 mg, 90 Tablets, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for Avkare, Pulaski, TN 38478, Product of Italy, NDC 42291-874-90. — Reason: Cross Contamination with Other Products — Status: Ongoing
Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5% Topical Ophthalmic Solution, 0.5mL Single-Use Syringe, For Topical Ophthalmic Use Only. Not for IV Use. Fagron Sterile Services, 8710 E 34th St N, Wichita, KS 67226. NDC: 71266-8240-01 — Reason: Incorrect Product Formulation — Status: Ongoing
Product code: QBJ. Advisory committee: Clinical Chemistry. Type: Special
Product code: OHS. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: NKB. Advisory committee: Orthopedic. Type: Special
Product code: MHX. Advisory committee: Cardiovascular. Type: Traditional
Product code: FOZ. Advisory committee: General Hospital. Type: Traditional
Product code: HEB. Advisory committee: Obstetrics/Gynecology. Type: Special
Product code: QVP. Advisory committee: Microbiology. Type: Special
Product code: HRS. Advisory committee: Orthopedic. Type: Traditional
Product code: QJU. Advisory committee: Radiology. Type: Traditional
Product code: NKB. Advisory committee: Orthopedic. Type: Traditional
Product code: FMF. Advisory committee: General Hospital. Type: Traditional
Product code: GDW. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: DYB. Advisory committee: Cardiovascular. Type: Traditional
Product code: DQY. Advisory committee: Cardiovascular. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Supplement type: 30-Day Notice. Product code: LWQ. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NQR. Advisory committee: NE. Decision: OK30
Supplement type: 30-Day Notice. Product code: LGW. Advisory committee: NE. Decision: OK30
Supplement type: 30-Day Notice. Product code: QQK. Advisory committee: GU. Decision: OK30
Supplement type: 30-Day Notice. Product code: FWM. Advisory committee: SU. Decision: OK30
Supplement type: 30-Day Notice. Product code: FTR. Advisory committee: SU. Decision: OK30
Supplement type: 30-Day Notice. Product code: MNQ. Advisory committee: AN. Decision: OK30
Supplement type: 30-Day Notice. Product code: LWR. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NIO. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: FTR. Advisory committee: SU. Decision: OK30
Supplement type: 30-Day Notice. Product code: NHL. Advisory committee: NE. Decision: OK30
Supplement type: 30-Day Notice. Product code: MNB. Advisory committee: OB. Decision: OK30
Supplement type: Normal 180 Day Track No User Fee. Product code: MHY. Advisory committee: NE. Decision: APPR
Supplement type: Real-Time Process. Product code: LOZ. Advisory committee: CV. Decision: APPR
Supplement type: Normal 180 Day Track No User Fee. Product code: SFA. Advisory committee: OR. Decision: APPR
Supplement type: 30-Day Notice. Product code: LWQ. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LYJ. Advisory committee: NE. Decision: OK30
Supplement type: Normal 180 Day Track No User Fee. Product code: QIT. Advisory committee: OP. Decision: APPR
Supplement type: 30-Day Notice. Product code: QVG. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: DSQ. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LWP. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NQR. Advisory committee: NE. Decision: OK30
Supplement type: 30-Day Notice. Product code: NIP. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: DSQ. Advisory committee: CV. Decision: OK30