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Week of Mar 17, 2025

35

Mar 19, 2025approval530d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

Sponsor: MERCK SHARP DOHME. Form: SOLUTION. Route: INTRAVENOUS

full page →pembrolizumab →fda approvals ↗

Mar 19, 2025approval530d agoMEKINIST (TRAMETINIB) — FDA approvalSpexotras

Sponsor: NOVARTIS. Form: SOLUTION. Route: ORAL

full page →Spexotras →fda approvals ↗

Mar 19, 2025approval530d agoTAFINLAR (DABRAFENIB MESYLATE) — FDA approvaldabrafenib mesylate ODT

Sponsor: NOVARTIS. Form: CAPSULE. Route: ORAL

full page →dabrafenib mesylate ODT →fda approvals ↗

Mar 19, 2025approval530d agoMEKINIST (TRAMETINIB DIMETHYL SULFOXIDE) — FDA approvalSpexotras

Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

full page →Spexotras →fda approvals ↗

Mar 19, 2025approval530d agoTAFINLAR (DABRAFENIB MESYLATE) — FDA approvaldabrafenib mesylate ODT

Sponsor: NOVARTIS. Form: CAPSULE. Route: ORAL

full page →dabrafenib mesylate ODT →fda approvals ↗

Mar 19, 2025recall530d agoChattem Inc recall (Cls II)Chattem Inc

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

full page →fda recalls ↗

Mar 19, 2025recall530d agoAspen Biopharma Labs Pvt., Ltd. recall (Cls II)GlaxoSmithKline LLC

Chlorambucil Container Description: The product packed in double self-seal cover and finally packed in Aluminum cover for shipping. — Reason: CGMP Deviations — Status: Ongoing

full page →fda recalls ↗

Mar 19, 2025recall530d agoAspen Biopharma Labs Pvt., Ltd. recall (Cls II)Teva Pharmaceuticals USA Inc

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

full page →fda recalls ↗

Mar 19, 2025recall530d agoKowa Pharmaceuticals America recall (Cls III)Kowa Pharmaceuticals America Inc

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

full page →fda recalls ↗

Mar 19, 2025recall530d agoDenison Pharmaceuticals, LLC recall (Cls II)Dendreon Pharmaceuticals LLC

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

full page →fda recalls ↗

Mar 19, 2025recall530d agoJohnson, S C and Son, Inc recall (Cls II)

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

full page →fda recalls ↗

Mar 19, 2025recall530d agoICU Medical, Inc. recall (Cls I)ICU MEDICAL INC/DE

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

full page →fda recalls ↗

Mar 19, 2025recall530d agoBreckenridge Pharmaceutical, Inc. recall (Cls II)Breckenridge Pharmaceutical Inc

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

full page →fda recalls ↗

Mar 19, 2025recall530d agoAspen Biopharma Labs Pvt., Ltd. recall (Cls II)PFIZER INC

Alprostadil Container Description: Amber color bottle — Reason: CGMP Deviations — Status: Ongoing

full page →fda recalls ↗

Mar 19, 2025recall530d agoBreckenridge Pharmaceutical, Inc. recall (Cls II)Breckenridge Pharmaceutical Inc

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

full page →fda recalls ↗

Mar 19, 2025recall530d agoNephron Sterile Compounding Center LLC recall (Cls II)Revalesio Corp

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

full page →fda recalls ↗

Mar 19, 2025recall530d agoAspen Biopharma Labs Pvt., Ltd. recall (Cls II)SpyGlass Pharma, Inc.

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

full page →fda recalls ↗

Mar 19, 2025recall530d agoCentral Admixture Pharmacy Services, Inc. recall (Cls I)Revalesio Corp

PHENYLephrine added to 0.9% sodium chloride, 40 mg/250 mL* (160 mcg/mL), Rx Only, CAPS, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, 855-275-2270, NDC 71285-6092-1. — Reason: Presence of Particulate Matter — Status: Ongoing

full page →fda recalls ↗

Mar 19, 2025recall530d agoBreckenridge Pharmaceutical, Inc. recall (Cls II)Breckenridge Pharmaceutical Inc

Duloxetine Delayed-Release Capsules, USP, 60mg, 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 51991-748-10 — Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. — Status: Ongoing

full page →fda recalls ↗

Mar 19, 2025recall530d agoSigan Industries Group Inc. recall (Cls II)AIR INDUSTRIES GROUP

Walgreens, Acne Control Cleanser, 10% Benzoyl Peroxide/Acne Treatment, NET WT 5 OZ (142g) Distributed by: Walgreen CO, 200 Wilmont RD, Deerfield, IL, Made in Canada. UPC#: 1 9560203602 8 — Reason: Chemical Contamination: Presence of benzene — Status: Ongoing

full page →fda recalls ↗

Mar 19, 2025recall530d agoAspen Biopharma Labs Pvt., Ltd. recall (Cls II)BioLight Israeli Life Sciences Ltd

Latanoprost NDC# 82187-1002-1 Container Description: Amber colour bottle — Reason: CGMP Deviations — Status: Ongoing

full page →fda recalls ↗

Mar 19, 2025recall530d agoICU Medical, Inc. recall (Cls I)ICU MEDICAL INC/DE

POTASSIUM CHLORIDE Inj., 20 mEq total in 100 mL flexible container 24 x case, 200 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7075-26; Bar Code Flexible container (01) 00309907075266; Case (01)30309907075267 — Reason: Labeling: Label Error on Declared Strength. Cases labeled POTASSIUM CHLORIDE 20 mEq, may contain flexible containers with overwrap mislabeled as 10 mEq. The correct dosage strength of 20 mEq is printed on the labeling affixed to the product flexible container. — Status: Ongoing

full page →fda recalls ↗

Mar 19, 2025recall530d agoJohnson, S C and Son, Inc recall (Cls II)

Kids by babyganics SPF 50 totally tropical (titanium dioxide 3/5%, zinc oxide 7.25%) packaged in a) 6 OZ (170 g) spray bottles UPC 813277019954 and UPC 813277019800; and b) Twinpack UPC 813277019930; Dist. by KAS Direct LLC, 1525 Howe St. Racine, WI 53403. — Reason: Chemical Contamination — Status: Ongoing

full page →fda recalls ↗

Mar 19, 2025recall530d agoCareFusion 213, LLC recall (Cls I)Coorg Instituite of Dental Sciences

BD ChloraPrep Clear 1mL Applicators, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin Preparation, Sterile Solution, 0.03 fl. oz (1 mL) each, 60 Applicators per Carton, CareFusion 213, LLC, El Paso, TX 79912, Subsidiary of Becton, Dickinson and Co., REF 930480, NDC 54365-400-31. — Reason: Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding. — Status: Ongoing

full page →fda recalls ↗

Mar 19, 2025recall530d agoAspen Biopharma Labs Pvt., Ltd. recall (Cls II)Greenstone LLC

Voriconazole Container Description: voriconazole 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

full page →fda recalls ↗

Mar 20, 2025approval529d agoBYLVAY (ODEVIXIBAT) — FDA approvalodevixibat

Sponsor: IPSEN. Form: CAPSULE. Route: ORAL

full page →odevixibat →fda approvals ↗

Mar 20, 2025approval529d agoTREMFYA (GUSELKUMAB) — FDA approvalguselkumab

Sponsor: JANSSEN BIOTECH. Form: INJECTABLE. Route: INJECTION

full page →guselkumab →fda approvals ↗

Mar 21, 2025approval528d agoNURTEC ODT (RIMEGEPANT SULFATE) — FDA approvalrimegepant sulfate ODT

Sponsor: PFIZER. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

full page →rimegepant sulfate ODT →fda approvals ↗

Mar 21, 2025approval528d agoPREZCOBIX (COBICISTAT) — FDA approvalGILEAD SCIENCES, INC.

Sponsor: JANSSEN PRODS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Mar 21, 2025approval528d agoOTULFI (USTEKINUMAB-AAUZ) — FDA approvalOTULFI

Sponsor: FRESENIUS KABI USA. Form: INJECTABLE. Route: INJECTION

full page →OTULFI →fda approvals ↗

Mar 21, 2025approval528d agoXTANDI (ENZALUTAMIDE) — FDA approvalenzalutamide

Sponsor: ASTELLAS. Form: TABLET. Route: ORAL

full page →enzalutamide →fda approvals ↗

Mar 21, 2025approval528d agoXTANDI (ENZALUTAMIDE) — FDA approvalenzalutamide

Sponsor: ASTELLAS. Form: CAPSULE. Route: ORAL

full page →enzalutamide →fda approvals ↗

Mar 21, 2025approval528d agoVYEPTI (EPTINEZUMAB-JJMR) — FDA approvalH. Lundbeck AS

Sponsor: Lundbeck Seattle BioPharmaceuticals, Inc.. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Mar 21, 2025approval528d agoVYEPTI (EPTINEZUMAB-JJMR) — FDA approvalH. Lundbeck AS

Sponsor: Lundbeck Seattle BioPharmaceuticals, Inc.. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Mar 21, 2025approval528d agoQULIPTA (ATOGEPANT) — FDA approvalatogepant

Sponsor: ABBVIE. Form: TABLET. Route: ORAL

full page →atogepant →fda approvals ↗

Week of Mar 24, 2025

15

Mar 24, 2025approval525d agoSPRAVATO (ESKETAMINE HYDROCHLORIDE) — FDA approvalJanssen Therapeutics

Sponsor: JANSSEN PHARMS. Form: SPRAY. Route: NASAL

full page →fda approvals ↗

Mar 24, 2025approval

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