Calendar

pharmadog

Week of Dec 22, 2025

Dec 23, 2025approval250d agoGLYCOPYRROLATE — FDA approvalGLYCOPYRROLATE

Sponsor: BIONPHARMA. Form: SOLUTION. Route: ORAL

full page →GLYCOPYRROLATE →fda approvals ↗

Dec 24, 2025approval249d agoCHILDREN'S ZYRTEC HIVES (CETIRIZINE HYDROCHLORIDE) — FDA approvalKenvue Inc.

Sponsor: KENVUE BRANDS. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗

Dec 24, 2025recall249d agoGolden State Medical Supply Inc. recall (Cls II)Beximco Pharmaceuticals USA Inc

Baclofen Tablets USP, 10 mg, 1000-count bottles, Rx only, Marketed by: GSMS, Incorporated, CA 93012 USA. NDC 51407-973-10 — Reason: Presence of Foreign Tablets/Capsules — Status: Ongoing

full page →fda recalls ↗

Dec 24, 2025recall249d agoSUN PHARMA /TARO recall (Cls II)ATLAS Molecular Pharma SL

Ciclopirox Shampoo, 1%, 120 mL, Rx only, Mfg by: Taro Pharmaceuticals Inc., Ontario, Canada; Dist. by: Taro Pharmaceuticals USA, Inc., NY 10532. NDC 51672-1351-08 — Reason: Failed Impurity/Degradation specifications: OOS results obtained at the 18-month timepoint — Status: Ongoing

full page →fda recalls ↗

Dec 24, 2025recall249d agoSOMERSET THERAPEUTICS LLC recall (Cls III)Somerset Therapeutics LLC

Cisatracurium Besylate Injection USP, 20 mg/10 mL*,(2 mg/mL), 10 x 10 mL Multiple-dose Vials per carton, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India, 10mL Multiple-dose vial, NDC 70069-161-01; 10x10mL Multiple-dose vials per Carton, NDC 70069-161-01. — Reason: Subpotent product:out of specification assay results observed during long term stability testing. — Status: Ongoing

full page →fda recalls ↗

Dec 24, 2025recall249d agoNovocol Pharmaceutical of Canada, Inc. recall (Cls II)

Benco dental Graham CHEMICAL CO., Mepivacaine HCI 3% (30 mg/mL) Injection, [Mepivacaine HCI Injection, USP], packaged in a carton containing 50 single-dose Cartridges, 1.7 mL each, Rx only, Distributed by Benco Dental 295 Center Point Blvd, Pittston, PA 18640, Manufactured by Novocol Pharmaceutical of Canada, Inc., NDC 66975-406-51. — Reason: Defective container: cracked/broken cartridges — Status: Ongoing

full page →fda recalls ↗

Dec 24, 2025recall249d agoPreferred Pharmaceuticals, Inc. recall (Cls II)InMed Pharmaceuticals Inc.

Ondansetron ODT Tablets, USP 4mg, 1x10 unit dose tablets, Mfg: Glenmark Pharmaceuticals Limited, Repackaged by Preferred Pharmaceuticals NDC 68788-8666-01 — Reason: Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale. — Status: Ongoing

full page →fda recalls ↗

Dec 24, 2025recall249d agoNovocol Pharmaceutical of Canada, Inc. recall (Cls II)

darby dental supply, MEPIVACAINE, Mepivacaine HCI 3% (30mg/mL) Injection, [Mepivacaine HCI Injection, USP], packaged in a carton containing 50 single-dose Cartridges, 1.7 mL each, Rx only, Manufactured by Novocol Pharmaceutical of Canada, Inc., NDC 66467-9760-5. — Reason: Defective container: cracked/broken cartridges — Status: Ongoing

full page →fda recalls ↗

Dec 24, 2025recall249d agoNovocol Pharmaceutical of Canada, Inc. recall (Cls II)DENTSPLY Pharmaceutical

3% Polocaine DENTAL, Mepivacaine Hydrochloride 3% (30mg/mL) (Mepivacaine HCI Injection, USP), packaged in a carton containing 50 single-dose Cartridges, 1.7 ml each, Rx only, Manufactured for Dentsply Pharmaceutical, York, PA 17404, by Novocol Pharmaceutical of Canada, Inc., NDC 66312-441-16. — Reason: Defective container: cracked/broken cartridges — Status: Ongoing

full page →fda recalls ↗

Dec 24, 2025recall249d agoSOMERSET THERAPEUTICS LLC recall (Cls III)Somerset Therapeutics LLC

Cisatracurium Besylate Injection USP, 200mg/20mL*(10mg/mL), 10 x 20 mL Single-dose Vials per Carton, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India, Single dose 20mL vial NDC 70069-151-01; 10 x 20 Single dose vials per Carton, NDC 70069-151-10. — Reason: Subpotent product:out of specification assay results observed during long term stability testing. — Status: Ongoing

full page →fda recalls ↗

Dec 24, 2025recall249d agoNovocol Pharmaceutical of Canada, Inc. recall (Cls II)DENTSPLY Pharmaceutical

2% Xylocaine DENTAL with Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Injection USP), packaged in a carton containing 50 single-dose cartridges, 1.7 mL each, Rx only, Manufactured for Dentsply Pharmaceutical, York, PA 17404, by Novocol Pharmaceutical of Canada, Inc., NDC 66312-176-16. — Reason: Defective container: cracked/broken cartridges — Status: Ongoing

full page →fda recalls ↗

Dec 24, 2025recall249d agoNovocol Pharmaceutical of Canada, Inc. recall (Cls II)Opus Genetics, Inc.

OraVerse, (Phentolamine Mesylate) Injection, 0.4 mg/1.7mL, packaged in a carton containing 10 cartridges, 0.4 mg/1.7mL, Rx only, Made in Canada by Novocol Pharmaceutical of Canada, Inc., Distributed by Septodont, Inc., Louisville, Co, 80027, NDC 0362-0101-10 — Reason: Defective container: cracked/broken cartridges — Status: Ongoing

full page →fda recalls ↗

Dec 24, 2025recall249d agoSOMERSET THERAPEUTICS LLC recall (Cls III)Somerset Therapeutics LLC

Cisatracurium Besylate Injection USP, 10 mg/5 mL* (2mg/mL), 10 x 5 mL Single-dose Vials per Carton, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India, Single-dose 5 mL vial NDC 70069-141-01; 10x5 mL single dose vial per Carton NDC 70069-141-10. — Reason: Subpotent product:out of specification assay results observed during long term stability testing. — Status: Ongoing

full page →fda recalls ↗

Dec 24, 2025recall249d agoNovocol Pharmaceutical of Canada, Inc. recall (Cls II)Fresenius Kabi USA LLC

Cook-Walte, Carbocaine 3% (30 mg/mL), (mepivacaine hydrochloride Injection, USP), packaged in a carton containing 50 Single-Dose Cartridges, 1.7 mL, Rx only, Manufactured by Novocol Pharmaceutical of Canada, Inc., NDC 0362-0753-05. — Reason: Defective container: cracked/broken cartridges — Status: Ongoing

full page →fda recalls ↗

Dec 24, 2025recall249d agoNovocol Pharmaceutical of Canada, Inc. recall (Cls II)International Medication Systems Ltd

Lidocaine HCI 2% and Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Injection USP), packaged in a carton containing 50 single-dose Cartridges, 1.7 ml each, Rx only, Manufactured for Patterson Dental Supply, Inc., 1031 Mendota Heights Road, Saint Paul, MN55120, Manufactured by: Novocol Pharmaceutical of Canada, Inc., NDC 50227-1030-5. — Reason: Defective container: cracked/broken cartridges — Status: Ongoing

full page →fda recalls ↗

Week of Dec 29, 2025

Dec 29, 2025approval244d agoTRAMADOL HYDROCHLORIDE — FDA approvaltramadol hydrochloride ER

Sponsor: SUN PHARM INDUSTRIES. Form: TABLET. Route: ORAL

full page →tramadol hydrochloride ER →fda approvals ↗

Dec 29, 2025approval

← prev

page 374 of 403

Week of Dec 22, 2025

Week of Dec 29, 2025