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20,557 catalysts · 4,728 grant · 3,374 device 510k · 3,086 8k filing · 2,856 approval · 2,000 device pma · 2,000 device recall
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20,557 catalysts · 4,728 grant · 3,374 device 510k · 3,086 8k filing · 2,856 approval · 2,000 device pma · 2,000 device recall
Sponsor: CENTOCOR ORTHO BIOTECH INC. Form: INJECTABLE. Route: INJECTION
Sponsor: JANSSEN BIOTECH. Form: INJECTABLE. Route: INJECTION
Sponsor: NEOS THERAPS. Form: TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE. Route: ORAL
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: MOF. Advisory committee: Cardiovascular. Type: Special
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: EGJ. Advisory committee: Physical Medicine. Type: Traditional
Product code: NAY. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: HEB. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: HSB. Advisory committee: Orthopedic. Type: Special
Product code: QKB. Advisory committee: Radiology. Type: Traditional
Product code: LZA. Advisory committee: General Hospital. Type: Special
Product code: NFO. Advisory committee: Neurology. Type: Traditional
Sponsor: NOVARTIS. Form: TABLET. Route: ORAL
Sponsor: NANJING KING FRIEND. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: ANTHEA PHARMA. Form: INJECTABLE. Route: INJECTION
METFORMIN HYDROCHLORIDE EXTENDED- RELEASE 500MG, 180 TABLETS, Packaged BY: A-S Medication Solutions, Libertyville, IL 60048 NDC 50090-1494-3. — Reason: Presence of Foreign Tablets/Capsules. — Status: Ongoing
fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.125% Bupivacaine HCl 125 mg/100 mL (1.25 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection for Epidural Use (Not intended For IV Use), Compounded, For Institutional or Office Use Only, QuVa Pharma, 1075 West Park One Drive, Suite 100, Sugar Land, Tx 77478. NDC: 70092-1255-75 — Reason: Lack of Assurance of Sterility — Status: Ongoing
[CORRECT FRONT PANEL] Hydrogen Peroxide Topical Solution, USP, 32 FL OZ (1 QT) 946 mL per bottle, NDC 0869-0871-45; [INCORRECT BACK LABEL] Isopropyl alcohol 91%, Dist. by: Amazon.com Services, LLC, Seattle, WA 98109. — Reason: Labeling; Label Mixup; some bottles have an incorrect back label indicating 91% Isopropyl Alcohol — Status: Ongoing
8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1 mEq/mL), 25 x 50 mL Single Dose Vials per carton, For Intravenous Use Only, Rx Only, Manufactured by: Exela Pharma Sciences, LLC, Lenoir, NC 28645. NDC Inner Vial: 51754-5001-1; NDC Carton: 51754-5001-4 — Reason: Lack of Assurance of Sterility — Status: Ongoing
SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg), 30-count All Natural USP Grade Saline Packets and 1 Soft tip Squeeze Bottle, Net WT 0.1OZ (3g) each, Distributed by Ascent Consumer Products Inc., Melville, NY 11747, UPC 6 46011 00104 1 — Reason: Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus — Status: Ongoing
SinuCleanse Soft Tip NETI POT Nasal Wash System (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg), 30-count All Natural USP Grade Saline Packets and 1 kettle style Neti Pot, Net WT 0.1OZ (3g) each, Distributed by Ascent Consumer Products Inc., Melville, NY 11747, UPC 6 46011 00102 7 — Reason: Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus — Status: Ongoing
fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.1% Bupivacaine HCl 100 mg/100 mL (1 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection for Epidural Use (Not intended For IV Use), Compounded, For Institutional or Office Use Only, QuVa Pharma, 1075 West Park One Drive, Suite 100, Sugar Land, Tx 77478. NDC: 70092-1255-75 — Reason: Lack of Assurance of Sterility — Status: Ongoing
SinuCleanse Premixed SALINE PACKETS (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg) for Nasal Wash System, 60-count All Natural USP Grade Saline Packets, Net WT 0.1OZ (3g) each, Distributed by Ascent Consumer Products Inc., Melville, NY 11747, UPC 6 46011 00103 4 — Reason: Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus — Status: Ongoing
Testosterone Gel 1%, 5 grams, 30 Unit-dose Packets in a carton, Rx only, Distributed by: Strides Pharma Inc., East Brunswick, NJ, NDC 64380-152-02 — Reason: Presence of foreign substance: Presence of Benzene. — Status: Ongoing
babyganics, Sheer Blend, SPF 50 Mineral Sunscreen Fragrance Free (zinc oxide 20%), a) 1.7 FL OZ (50 mL) bottle, UPC 810035921658, b) 8 FL OZ (236 mL) bottle, UPC 810035921382, Dist. by KAS Direct, LLC, 1525 Howe St., Racine, WI 53403, Made in Canada. — Reason: Failed stability specifications: during routine stability monitoring quality concerns were identified. Physical separation for ingredients was observed. — Status: Ongoing
fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.2% ROPivacaine HCl 200 mg/100 mL (2 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection for Epidural Use (Not intended For IV Use), Compounded, For Institutional or Office Use Only, QuVa Pharma, 1075 West Park One Drive, Suite 100, Sugar Land, Tx 77478. NDC: 70092-1259-75 — Reason: Lack of Assurance of Sterility — Status: Ongoing
Testosterone Gel 1%, 2.5 grams, 30 Unit-dose packets in a carton, Rx only, Distributed by: Strides Pharma Inc., East Brunswick, NJ, NDC 64380-151-02 — Reason: Presence of foreign substance: Presence of Benzene. — Status: Ongoing
Product code: JXI. Advisory committee: Neurology. Type: Traditional
Product code: FRN. Advisory committee: General Hospital. Type: Traditional
Product code: QFG. Advisory committee: Clinical Chemistry. Type: Special
Product code: JWH. Advisory committee: Orthopedic. Type: Special
Product code: LOD. Advisory committee: Orthopedic. Type: Special
Product code: FRN. Advisory committee: General Hospital. Type: Traditional
Product code: QNQ. Advisory committee: General Hospital. Type: Traditional
Product code: HDR. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: OLO. Advisory committee: Neurology. Type: Traditional
Product code: NUH. Advisory committee: Neurology. Type: Traditional
Product code: FET. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: JXI. Advisory committee: Neurology. Type: Traditional
Product code: KNF. Advisory committee: Obstetrics/Gynecology. Type: Special
Product code: PHC. Advisory committee: General Hospital. Type: Traditional
Product code: HWC. Advisory committee: Orthopedic. Type: Special
Product code: DQX. Advisory committee: Cardiovascular. Type: Special
Product code: HGX. Advisory committee: Obstetrics/Gynecology. Type: Special
Sponsor: SPECGX LLC. Form: TABLET. Route: ORAL
Sponsor: WES PHARMA INC. Form: TABLET. Route: ORAL
Sponsor: VIELA BIO. Form: INJECTABLE. Route: INJECTION
Product code: QIH. Advisory committee: Radiology. Type: Traditional