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23,058 catalysts · 4,728 grant · 4,703 device 510k · 3,486 approval · 3,350 8k filing · 2,000 device pma · 2,000 device recall
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23,058 catalysts · 4,728 grant · 4,703 device 510k · 3,486 approval · 3,350 8k filing · 2,000 device pma · 2,000 device recall
LITE Regener-Eyes, Ophthalmic Solution (glycerin 0.4%), 3mL bottles, Distributed by: Regener-Eyes, Tampa, FL; Manufactured by: Regenerative Processing Plant, LLC, 34176 US HWY 19N, FL, NDC 82305-006-01 — Reason: Lack of Sterility Assurance — Status: Terminated
Pearson Quality, Topical Anesthetic Gel, 20% Benzocaine, For Professional Use Only, Net Contents: 1 oz (30 g), Manufactured for Pearson Dental Supply Inc., Sylmar, CA 91342 USA. — Reason: CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers. — Status: Completed
VCF, Vaginal Contraceptive Gel, Birth Control, 10 Pre-filled Applicators, Net Wt. 0.09 oz (2.55g) Each, Distributed By: Apothecus Pharmaceutical Corp., Ronkonkoma, NY 11779, NDC 52925-512-10 — Reason: CGMP deviations: out of specifications for assay — Status: Ongoing
M&S Dental Supply Co LLC., Topical Anesthetic Gel, Benzocaine 20%, Net Wt. 1 oz. (30ml), Manufactured for: M&S Dental Supply Co LL, 105-30 101 Avenue, Ozone Park, NY 11416. — Reason: CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers. — Status: Completed
Nebivolol Tablets, 2.5. mg, 30-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520. NDC: 59651-137-30 — Reason: CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) limit. — Status: Ongoing
Ipana, 20% Benzocaine Topical Gel, 28g, Maxill Inc., St Thomas ON Canada. — Reason: CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers. — Status: Completed
Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540, Manufactured for: Macleods Pharma USA Inc. Princeton, NJ,08540: Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi Himachal Pradesh, INDIA, NDC 33342-067-07. — Reason: Failed Impurities/Degradation Specifications — Status: Ongoing
Burkhart, Topical Anesthetic Gel, Benzocaine 20%, Gluten Free, 1 FL. OZ (30 ml), Manufactured for Burkhart Dental Supply, Tacoma, Washington 98409. — Reason: CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers. — Status: Completed
Patterson Dental, Patterson Topical Anesthetic Gel, Benzocaiine, 1 oz. (30 ml), Manufactured for (Fabrique pour): Patterson Dental Supply, Inc. 1031 Mendota Heights Road, Saint Paul, MN 55120, NDC 50227-1002-3. — Reason: CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers. — Status: Completed
PROFESSIONAL Regener-Eyes, Ophthalmic Solution (glycerin 0.5%) , 3mL bottles, Distributed by: Regener-Eyes, Tampa, FL; Manufactured by: Regenerative Processing Plant, LLC, 34176 US HWY 19N, FL, NDC 82305-003-01 — Reason: Lack of Sterility Assurance — Status: Terminated
Sponsor: RIDGEBACK BIOTHERAPEUTICS. Form: POWDER. Route: IV (INFUSION)
Sponsor: AMGEN INC. Form: INJECTABLE. Route: INTRAVENOUS, SUBCUTANEOUS
Sponsor: AMGEN INC. Form: INJECTABLE. Route: INTRAVENOUS, SUBCUTANEOUS
Product code: PNP. Advisory committee: Dental. Type: Traditional
Product code: JDR. Advisory committee: Orthopedic. Type: Special
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: PBX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: ONB. Advisory committee: General Hospital. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: GXH. Advisory committee: Neurology. Type: Special
Sponsor: BRISTOL-MYERS SQUIBB. Form: INJECTABLE. Route: SUBCUTANEOUS
Product code: ELW. Advisory committee: Dental. Type: Abbreviated
Product code: ITI. Advisory committee: Physical Medicine. Type: Traditional
Product code: QZL. Advisory committee: Radiology. Type: Special
Product code: DZE. Advisory committee: Dental. Type: Traditional
Product code: OXO. Advisory committee: Radiology. Type: Traditional
Product code: DZE. Advisory committee: Dental. Type: Traditional
Product code: HAW. Advisory committee: Neurology. Type: Traditional
Product code: OUR. Advisory committee: Orthopedic. Type: Special
Product code: PZZ. Advisory committee: Pathology. Type: Traditional
Sponsor: KADMON PHARMS LLC. Form: TABLET. Route: ORAL
Product code: QPB. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: QJP. Advisory committee: Cardiovascular. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: CBK. Advisory committee: Anesthesiology. Type: Traditional
Sponsor: JANSSEN PHARMS. Form: SPRAY. Route: NASAL
Sponsor: SCIEGEN PHARMS. Form: TABLET. Route: ORAL
Sponsor: SCIEGEN PHARMS. Form: TABLET. Route: ORAL
Sponsor: SCIEGEN PHARMS. Form: TABLET. Route: ORAL
Sponsor: SCIEGEN PHARMS. Form: CAPSULE. Route: ORAL
Sponsor: SCIEGEN PHARMS. Form: CAPSULE. Route: ORAL
Sponsor: SCIEGEN PHARMS. Form: CAPSULE. Route: ORAL
Sponsor: LAURUS. Form: TABLET. Route: ORAL
Sponsor: LAURUS. Form: CAPSULE. Route: ORAL
Product code: BTA. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: ITI. Advisory committee: Physical Medicine. Type: Traditional
Product code: MAX. Advisory committee: Orthopedic. Type: Special
Product code: ITI. Advisory committee: Physical Medicine. Type: Traditional
Product code: BZD. Advisory committee: Anesthesiology. Type: Special