BD is recalling certain BD Intraosseous Vascular Access System Needle Sets due to difficulty removing the obturator (stylet) following placement.
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Zen Principle Naturals Moringa Leaf Powder dietary supplement, 900mg capsules, 180 capsules per PET white bottle. Intended Use: take 2 capsules per day. Route…
Possible Salmonella in Moringa Leaf Powder product.
Read MoreEarly Alert: Nitric Oxide Delivery System Issue from NOxBOX
The NOxBOX NOxBOXi System may leak oxygen during inhaled nitric oxide therapy
Read MoreDicyclomine Hydrochloride Capsules, USP, 10mg, 1,000 bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in…
shortfill; reports of empty capsules.
Read MoreCyclophosphamide for Injection, USP, 2 gram/vial, One Single-Dose Vial, Rx only, Manufactured for: Long Grove Pharmaceuticals, LLC, Rosemont, IL 60018. Manufactured in Taiwan, NDC…
Presence of Particulate Matter; identified as stainless steel
Read MoreNitric Oxide Delivery System Correction: NOxBOX Updates Use Instructions for NOxBOXi Nitric Oxide Delivery System
The NOxBOX NOxBOXi System may leak oxygen during inhaled nitric oxide therapy
Read MoreTotal Parental Nutrition – Pediatric PN Patient-Specific TPN Bag, (patient specific), Compound Volume 416.8 mL per bag, Rx only, Single Dose Injection, Refrigerated Injection,…
Incorrect Product Formulation
Read MoreMirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Matoda, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington,…
CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
Read MoreCyclophosphamide for Injection, USP, 1 gram/vial, One Single-Dose Vial, Rx only, Manufactured for: Long Grove Pharmaceuticals, LLC, Rosemont, IL 60018. Manufactured in Taiwan, NDC…
Presence of Particulate Matter; identified as stainless steel
Read MoreDabigatran Etexilate Capsules, 75 mg, 30-count (3×10) blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed…
Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities…
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