Drugs & medicalClass II

SUN PHARMACEUTICAL INDUSTRIES INC recalls Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg, 30-count bottles, Rx only, Distributed by: Sun Pharmaceutical…

Presence of Foreign Substance

Read the official notice →
Date
2022-11-09
Country
United States
Brand
Sun Pharmaceutical Industries
Product
Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg, 30-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc.…
Classification
Class II
Units
Nationwide with the United States
Category
Drugs & medical
Source
FDA · Drug

Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer

What to do

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. Ask the pharmacy or supplier about a replacement or refund.

General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.

More Sun Pharmaceutical Industries recalls

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    Failed Impurity (Deacetyl Diltiazem Hydrochloride) specification during stability testing and failed dissolution testing at FDA laboratory.

    FDA · DrugSUN PHARMACEUTICAL INDUSTRIES INCNationwide in the U.S.Official notice →
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    SUN PHARMACEUTICAL INDUSTRIES INC recalls Oxcarbazepine Tablets 600mg, packaged in a) 100- count bottles (NDC 62756-185-88), b) 500-count bottles (NDC 62756-185-13),…

    Presence of foreign substance

    FDA · DrugSUN PHARMACEUTICAL INDUSTRIES INCNationwide within the United StatesOfficial notice →
  5. 2022-11-30
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  7. 2022-10-05
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    Superpotent Drug: Out of specification for assay at the 12-month timepoint.

    FDA · DrugSUN PHARMACEUTICAL INDUSTRIES INCNationwide in the USAOfficial notice →
  9. 2022-08-03
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    SUN PHARMACEUTICAL INDUSTRIES INC recalls Divalproex Sodium Delayed-Release Tablets, USP 500mg, Rx Only, 100 Tablets, Distributed by: Sun Pharmaceutical Industries,…

    Failed Dissolution Specifications: Failure occurred during routine stability testing of dissolution test.

    FDA · DrugSUN PHARMACEUTICAL INDUSTRIES INCNationwide in the USAOfficial notice →
  11. 2022-07-20
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All 57 Sun Pharmaceutical Industries recalls →

Other drugs & medical recalls in the United States

  1. 2022-11-09
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    Baxter Healthcare Corporation recalls Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for Progressa Bed, Product Code/Part Number P00697903.

    Radio frequency emission from a functioning WatchCare device may potentially impact other devices (including, but not limited to telemetry devices, bladder scanner, fetal monitor/doppler, infusion pumps, and insulin…

    FDA · DeviceBaxter Healthcare CorporationUSOfficial notice →
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    Pharmacy Plus, Inc. dba Vital Care Compounder recalls MEDROXYPROGESTERONE ACETATE 300 MG/ML Suspension, 10 mL vial, Rx only, Vital Care Compounder, 115 S. 40th Ave.,…

    Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.

    FDA · DrugPharmacy Plus, Inc. dba Vital Care CompounderAL, LA, MS, and TNOfficial notice →
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    Genentech Inc recalls Susvimo (ranibizumab injection), 100mg/mL, sold together as a) carton containing One Susvimo single-dose vial and One Susvimo initial fill…

    Defective Delivery System: Commercial implants do not meet the filed specification for the intended use, a few patients have experienced an issue with the implants that renders it non-functioning.

    FDA · DrugGenentech IncNationwide in the USAOfficial notice →
  5. 2022-11-02
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    Wright Medical Technology, Inc. recalls Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 16mm Stem Base, REF 200252903, Size 3

    The tibial tray lock detail is oversized (larger than specification).

    FDA · DeviceWright Medical Technology, Inc.US Nationwide distribution in the state of New York.Official notice →
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    Biopsy Systems have components that are misaligned due to an issue with the manufacturing assembly equipment, which may lead to the needle ejecting when triggered outside the body, which may result in user or patient…

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    W L Gore & Associates, Inc. recalls GORE CARDIOFORM ASD Occluder. cardiovascular implant.

    Due to manufacturing records (Release Test Results) indicating "Failed".

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