Early Alert: Stent and Electrocautery-Enhanced Delivery System Issue from Boston Scientific
Boston Scientific is removing certain stents and delivery systems due to issues with deployment and expansion.
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Lupin Limited – 09/16/2025
Lupin Limited – 09/16/2025. Country: India. Record Type: 483 -
Guidance: Route B substantial modification pilot
Clinical trials Route B substantial modifications pilot starts on 1 October 2025. Prepare for the implementation of new regulations from 28 April 2026.
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Class 3 Medicines Recall: Glenmark Pharmaceuticals Europe Limited, Fingolimod Glenmark 0.5 mg Hard Capsules, EL(26)A/02
Glenmark Pharmaceuticals Europe Limited is recalling one batch after stability testing showed out-of-specification results. The batch is being recalled as a precautionary measure following test results that showed a delay in capsule dissolution.
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Fresenius Kabi Compounding LLC. Canton, MA. 483 issued 11/05/2025
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 11/05/2025
Short Title (70 char) Fresenius Kabi Compounding LLC. Canton, MA. 483 issued 11/05/2025
FEI Number 3013438665
Firm Name Fresenius Kabi Compounding LLC
Record Type 483
State MA
Establishment Type Outso -
JKR Pharmacy Ventures, LLC dba Doc Lane’s Veterinary Pharmacy. Lexington, KY. 483 issued 12/19/2025
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 12/19/2025
Short Title (70 char) JKR Pharmacy Ventures, LLC dba Doc Lane’s Veterinary Pharmacy. Lexington, KY. 483 issued 12/19/2025
FEI Number 3033262505
Firm Name JKR Pharmacy Ventures, LLC
Record Type 483
Sta -
M4Q(R2) The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality
M4Q(R2) The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality -
Class 2 Medicines Recall: Mercury Pharmaceuticals Ltd, Paliperidone Mercury Pharma prolonged-release suspension for injection in pre-filled syringes, EL(26)A/01
Mercury Pharmaceuticals Ltd is recalling remaining stock of paliperidone pre-filled syringes as a precautionary measure due to Good Manufacturing Practice (GMP) deficiencies cited during a recent inspection at the finished product manufacturing site.
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Tri-Union Seafoods Identifies Additional Quantities of Recalled Genova® Tuna at Limited Retailers Due to Inadvertent Distribution of Previously Recalled Product
El Segundo, CA, January 16, 2026 – Tri-Union Seafoods is cautioning consumers that a third-party distributor inadvertently released quarantined product that was associated to a February 2025 recall. The initial voluntary recall was conducted following notification from our supplier that the “easy op -
MHRA scientists contribute to international study on novel oral polio vaccine stability
Study confirms vaccine being used in global efforts to achieve and sustain polio eradication is successfully interrupting polio outbreaks whilst minimising risk of new vaccine-derived outbreaks in Uganda
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MHRA statement on new review of paracetamol safety during pregnancy
Paracetamol should be taken as directed in the patient information leaflet.
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Olympus Expands Voluntary Recall for ViziShot 2 FLEX (19G) EBUS -TBNA Needles
CENTER VALLEY, Pa., (January 16, 2026) — Olympus Corporation has announced the expansion of a previous global medical device removal action for ViziShot 2 FLEX (19G) EBUS -TBNA needles (“ViziShot 2 FLEX”) after receiving and investigating complaints of device components ejecting or detaching during