Drugs & medicalClass II

SUN PHARMACEUTICAL INDUSTRIES INC recalls Buprenorphine Sublingual Tablets, 8 mg, 30 count-bottles, Rx only, Manufactured by: Sun Pharma, NDC 62756-460-83.

CGMP Deviations

Read the official notice →
Date
2023-06-14
Country
United States
Brand
Sun Pharmaceutical Industries
Product
Buprenorphine Sublingual Tablets, 8 mg, 30 count-bottles, Rx only, Manufactured by: Sun Pharma, NDC 62756-460-83.
Classification
Class II
Units
Product was distributed to 19 distributors nationwide.
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 Details may be shortened or out of date; the official notice is the authoritative source.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

  1. 2023-07-26
  2. US
    Drugs & medicalClass III

    SUN PHARMACEUTICAL INDUSTRIES INC recalls Loteprednol Etabonate Ophthalmic Suspension, 5 mg/mL (0.5%), packaged as one bottle in a carton in a) 10 mL bottle (NDC#…

    Superpotent Drug: Out of Specification (OOS) results observed for unit dose content.

    FDA · DrugSUN PHARMACEUTICAL INDUSTRIES INCUSA nationwide.Official notice →
  3. 2023-07-19
  4. US
    Drugs & medicalClass II

    SUN PHARMACEUTICAL INDUSTRIES INC recalls Tiagabine Hydrochloride Tablets, 2 mg, 30-count bottle, Distributed by Sun Pharmaceutical Industries. Inc. Cranbury NJ 08512,…

    Failed Impurities: Out of Specification (OOS) result observed during Related Substances testing

    FDA · DrugSUN PHARMACEUTICAL INDUSTRIES INCDistributed nationwide in the USA.Official notice →
  5. 2023-07-05
  6. US
  7. 2023-05-31
  8. US
    Drugs & medicalClass II

    SUN PHARMACEUTICAL INDUSTRIES INC recalls buPROPrion Hydrochloride Extended-Release Tablets, USP (SR) 150 mg, 60 Tablets, Rx Only, Distributed by: Sun Pharmaceutical…

    Failed Dissolution Specifications; during stability testing

    FDA · DrugSUN PHARMACEUTICAL INDUSTRIES INCNationwide in the U.S.AOfficial notice →
  9. 2023-05-03
  10. US
    Drugs & medicalClass II

    Sun Pharmaceutical Industries Ltd. recalls Fyremadel (ganirelix acetate) injection, 250 mcg/0.5 mL, One Single Dose Sterile Prefilled Syringe 0.5 mL, For Subcutaneous…

    Presence of Particulate Matter: A piece of glass was found in a prefilled syringe.

    FDA · DrugSun Pharmaceutical Industries Ltd.Nationwide in the USAOfficial notice →
  11. 2023-04-19
  12. US
    Drugs & medicalClass III

    SUN PHARMACEUTICAL INDUSTRIES INC recalls Norepinephrine Bitartrate Injection, USP, 4 mg/4 mL* (1 mg/mL), 4 mL Single-dose Fliptop Vial (NDC 47335-615-40); packaged in…

    Failed Impurities/Degradation Specifications: Above the specification limits yielded for related substance norepinephrine sulfonic acid impurity during routine product monitoring.

    FDA · DrugSUN PHARMACEUTICAL INDUSTRIES INCNationwide in the USAOfficial notice →
All 57 Sun Pharmaceutical Industries recalls →

Other drugs & medical recalls in the United States

  1. 2023-06-14
  2. US
    Drugs & medicalClass I

    BearCare, Inc. recalls Walnut Wearable Smart Thermometer, intended for continuous chest temperature monitoring of children ages 0-6 years in non-emergency…

    There have been reports of skin burns to children wearing the device.

    FDA · DeviceBearCare, Inc.US Nationwide distribution.Official notice →
  3. US
    Drugs & medicalClass I

    Medtronic Navigation, Inc. recalls StealthStation Cranial Software, Models: 9735585, 9735586 (kit), 9735587 (kit), used with StealthStation S7/i7 systems

    During non-axial/some axial exams, software anomalies occur during procedures affecting depth gauge graphic displays for cranial biopsy; causing displays to no longer synchronize with other navigational information…

    FDA · DeviceMedtronic Navigation, Inc.Worldwide Distibution: US (nationwide): OH, IL, CA, MI, FL, LA, OK, WA, AR,…Official notice →
  4. US
  5. US
    Drugs & medicalClass II

    Golden State Medical Supply Inc. recalls Travoprost Ophthalmic Solution, USP (Ionic Buffered Solution), 0.004%, Rx only, Manufactured by Apotex Inc., Manufactured by:…

    Lack of Assurance of Sterility: Tamper Evidence Seal is missing on secondary container.

    FDA · DrugGolden State Medical Supply Inc.Nationwide in the USAOfficial notice →
  6. US
    Drugs & medicalClass II

    Viatris Inc recalls Levsin injection (hyoscyamine sulfate injection, USP), 0.5 mg per ml in water for Injection, 1 ml Ampule (Box of 5 ampules), Rx Only,…

    CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.

    FDA · DrugViatris IncProduct was distributed to 10 distributors who may have further distribute the…Official notice →
  7. US
    Drugs & medicalClass II

    Empower Clinic Services LLC dba Empower Pharmacy recalls ASCORBIC ACID PRESERVED INJECTION SOLUTION, 500 mg/mL, 30 mL Sterile Multiple-Dose Vial, RX ONLY, Compounded…

    Mislabeling: preservative free product labeled as preserved.

    FDA · DrugEmpower Clinic Services LLC dba Empower PharmacyDistributed Nationwide in the USAOfficial notice →
See all drugs & medical recalls →