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21,759 catalysts · 4,728 grant · 4,071 device 510k · 3,208 8k filing · 3,114 approval · 2,000 device pma · 2,000 device recall
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21,759 catalysts · 4,728 grant · 4,071 device 510k · 3,208 8k filing · 3,114 approval · 2,000 device pma · 2,000 device recall
Product code: PTI. Advisory committee: General Hospital. Type: Special
Product code: LON. Advisory committee: Microbiology. Type: Traditional
Product code: OLO. Advisory committee: Neurology. Type: Traditional
Product code: QZB. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: KRD. Advisory committee: Cardiovascular. Type: Traditional
Product code: DYB. Advisory committee: Cardiovascular. Type: Special
Sponsor: MYLAN PHARMS INC. Form: CAPSULE. Route: ORAL
Sponsor: ACCORD BIOPHARMA INC.. Form: INJECTABLE. Route: INTRAVENOUS
Product code: OVD. Advisory committee: Orthopedic. Type: Traditional
Product code: OAN. Advisory committee: Neurology. Type: Traditional
Product code: GCJ. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: LLZ. Advisory committee: Radiology. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Special
Product code: IRP. Advisory committee: Physical Medicine. Type: Traditional
Product code: OBP. Advisory committee: Neurology. Type: Traditional
Product code: HRS. Advisory committee: Orthopedic. Type: Special
Product code: LNH. Advisory committee: Radiology. Type: Traditional
Product code: OWB. Advisory committee: Radiology. Type: Traditional
Product code: FIP. Advisory committee: Gastroenterology, Urology. Type: Special
Product code: MYC. Advisory committee: Ophthalmic. Type: Traditional
Product code: IYE. Advisory committee: Radiology. Type: Traditional
Product code: MQC. Advisory committee: Unknown. Type: Traditional
Product code: HRS. Advisory committee: Orthopedic. Type: Special
Product code: MQB. Advisory committee: Radiology. Type: Traditional
Product code: OHS. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: POD. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: MAX. Advisory committee: Orthopedic. Type: Traditional
Product code: LZA. Advisory committee: General Hospital. Type: Traditional
Product code: NZE. Advisory committee: Cardiovascular. Type: Traditional
Product code: LQR. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: LLZ. Advisory committee: Radiology. Type: Traditional
Product code: DJC. Advisory committee: Clinical Toxicology. Type: Traditional
Product code: QDQ. Advisory committee: Radiology. Type: Traditional
Sponsor: MERCK SHARP DOHME. Form: SOLUTION. Route: INTRAVENOUS
Sponsor: NOVARTIS. Form: SOLUTION. Route: ORAL
Sponsor: NOVARTIS. Form: CAPSULE. Route: ORAL
Sponsor: NOVARTIS. Form: TABLET. Route: ORAL
Sponsor: NOVARTIS. Form: CAPSULE. Route: ORAL
Unisom, SleepMelts, Diphenhydramine HCl tablets, 25 mg, Nighttime Sleep-Aid, 4 x 8 blister packs per carton, Cherry flavor, Manufactured by Adare Pharmaceuticals, Inc., Dist. by Chattem, Inc., P.O. Box 2219, Chattanooga, TN 37409, UPC # 0 41167 0014 0 — Reason: CGMP Deviations: Nitrosamine Drug Substance Related Issue impurity above the daily acceptable intake limit defined by the Food and Drug Administration. — Status: Ongoing
Chlorambucil Container Description: The product packed in double self-seal cover and finally packed in Aluminum cover for shipping. — Reason: CGMP Deviations — Status: Ongoing
Finasteride NDC# 82187-1003-1 Container Description: The product packed in white poly bag containing black poly bag and tied each individual finally packed in HDPE container for shipping. — Reason: CGMP Deviations — Status: Ongoing
Livalo (pitavatstatin) tablets, 4 mg, 90-count bottles, Rx only, Manufactured by: Patheon, Inc. Cincinnati, OH 45237 USA or by Kowa Company, Ltd, Nagoya, 462-0024 Japan, Marketed by Kowa Pharmaceuticals: Kowa Pharmaceuticals America Inc., Montgomery, AL 36117 USA NDC 66869-404-90 HDPE Bottle, congregated into a shrink wrapped 6-pack further congregated into 24 6-packs in a cardboard case — Reason: Presence of foreign tablets/capsules — Status: Completed
Zapzyt, Acne Treatment Gel, 10% benzoyl peroxide Gel, packaged in 1 oz (28.35g) tube, Distributed by: FOCUS CONSUMER HEALTHCARE, LLC., 801 Broad St Ste 200, Chattanooga, TN 37402. NDC 71687-0011-1 — Reason: Chemical Contamination: Presence of benzene. — Status: Ongoing
Kids by babyganics SPF 50 mineral sunscreen totally tropical (titanium dioxide 3/5%, zinc oxide 7.25%), packaged in 3 OZ spray bottles, Dist. by KAS Direct LLC, 1525 Howe St. Racine, WI 53403, UPC 813277019923 and UPC 813277019916 — Reason: Chemical Contamination — Status: Ongoing
POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL, 100 mEq/L flexible container, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7074-26; Bar Code (01)00309907074269 — Reason: Labeling: Label Error on Declared Strength. Overwrap labeled as Potassium Chloride Inj 10 mEq may contain flexible containers of Potassium Chloride Inj 20 mEq — Status: Ongoing
Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-746-05 — Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. — Status: Ongoing
Alprostadil Container Description: Amber color bottle — Reason: CGMP Deviations — Status: Ongoing
Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 1000-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-747-10 — Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. — Status: Ongoing
Sodium Chloride Injection 9%, USP, 500 mL, Single-Dose IV Bottle, Rx Only, nephron, 503B outsourcing facility, West Columbia, SC 29172, NDC: 69374-334-50 — Reason: Lack of Assurance of Sterility: There is a potential for leakage at the IV bottle port. — Status: Terminated
Bimatoprost NDC# 82187-1001-1 Container description: The product packed in double self-seal cover and finally packed in Aluminum cover for shipping. — Reason: CGMP Deviations — Status: Ongoing