Drugs & medicalClass II

Breckenridge Pharmaceutical, Inc recalls Alprazolam Tablets, USP, 1 mg, CIV, packaged in: a) 100-count bottle (NDC 51991-0706-01), b) 500-count bottle (NDC…

CGMP Deviations: Potential risk of Cross Contamination

Read the official notice →
Date
2023-03-22
Country
United States
Brand
Breckenridge Pharmaceutical
Product
Alprazolam Tablets, USP, 1 mg, CIV, packaged in: a) 100-count bottle (NDC 51991-0706-01), b) 500-count bottle (NDC 51991-0706-05) and c)…
Classification
Class II
Units
USA 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Breckenridge Pharmaceutical recalls

  1. 2025-04-09
  2. US
    Drugs & medicalClass II

    Breckenridge Pharmaceutical, Inc. recalls Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx Only, 1,000 Capsules per bottle, Manufactured by: Towa Pharmaceutical…

    CGMP Deviations: presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the recommended interim limit.

    FDA · DrugBreckenridge Pharmaceutical, Inc.Nationwide in the USOfficial notice →
  3. 2025-03-19
  4. US
    Drugs & medicalClass II

    Breckenridge Pharmaceutical, Inc. recalls Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L.…

    CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.

    FDA · DrugBreckenridge Pharmaceutical, Inc.NationwideOfficial notice →
  5. 2025-01-01
  6. US
    Drugs & medicalClass II

    Breckenridge Pharmaceutical, Inc recalls Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 90-count bottles (NDC 51991-747-90) Mfr. by: Towa Pharmaceutical…

    CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.

    FDA · DrugBreckenridge Pharmaceutical, IncNationwide in the USOfficial notice →
  7. 2024-10-23
  8. US
    Drugs & medicalClass II

    Breckenridge Pharmaceutical, Inc recalls Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L.…

    CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

    FDA · DrugBreckenridge Pharmaceutical, IncProduct was distributed nationwide within the United StatesOfficial notice →
  9. 2024-06-26
  10. US
    Drugs & medicalClass II

    Breckenridge Pharmaceutical, Inc recalls Duloxetine Delayed-Release Capsules, USP, 60mg, 90-count bottle, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles,…

    CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

    FDA · DrugBreckenridge Pharmaceutical, IncNationwide in the USAOfficial notice →
  11. 2024-05-15
  12. US
    Drugs & medicalClass II

    Breckenridge Pharmaceutical, Inc recalls Duloxetine Delayed-Release Capsules, USP, 60 mg, 90-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L.…

    CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

    FDA · DrugBreckenridge Pharmaceutical, IncUS Nationwide.Official notice →
All 16 Breckenridge Pharmaceutical recalls →

Other drugs & medical recalls in the United States

  1. 2023-03-22
  2. US
    Drugs & medicalClass III

    Zydus Pharmaceuticals (USA) Inc recalls Colchicine Tablets, USP 0.6 mg, Rx Only, a) 30 tablets per bottle, NDC 16714-0039-01, b) 100 tablets per bottle, NDC…

    Failed Impurities/Degradation Specifications: An out-of-specification (OOS) result was observed during release testing of one lot for a related substance, i.e. Beta-lumicolchicine.

    FDA · DrugZydus Pharmaceuticals (USA) IncAZ, OH, MS.Official notice →
  3. US
    Drugs & medicalClass III

    AVEVA Drug Delivery Systems, Inc. recalls Buprenorphine Transdermal System, CIII 20 mcg/hour, 4 Transdermal Systems One package of 4 disposal units, Rx Only,…

    Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydroxy buprenorphine N-Oxide results generated at the 18-month stability timepoint.

    FDA · DrugAVEVA Drug Delivery Systems, Inc.NationwideOfficial notice →
  4. US
    Drugs & medicalClass III

    Padagis US LLC recalls Evamist (estradiol transdermal spray), 1.53 mg of estradiol per spray, 0.27 fl oz (8.1 mL) per metered-dose pump, Rx Only, Manufactured by…

    Failed Content Uniformity Specifications: The Spray Content Uniformity (SCU) requirement for Standard Deviation did not meet the requirement at the 18-month stability time point.

    FDA · DrugPadagis US LLCNationwide in the USAOfficial notice →
  5. 2023-03-16
  6. US
    Drugs & medical

    Pfizer Recalls Nurtec ODT Prescription Drugs Due to Failure to Meet Child Resistant Packaging Requirement; Risk of Poisoning

    The recalled prescription drugs must be in child resistant packaging as required by the Poison Prevention Packaging Act (PPPA). The packaging of the products is not child resistant, posing a risk of poisoning if the…

    CPSCBiohaven Pharmaceuticals Inc., of New Haven, Conn.About 4.2 millionOfficial notice →
  7. 2023-03-15
  8. US
    Drugs & medicalClass II

    Carefusion 2200 Inc recalls CD5 Series of Genesis Reusable Rigid Sterilization Container Systems catalog number and product name: 1. CD5-3B, CONTAINER SHALLOW LG ENDO…

    Product did not meet shelf-life testing requirements resulting in a breach of the sterility of the Genesis container holding surgical equipment.

    FDA · DeviceCarefusion 2200 IncWorldwide distribution - US Nationwide, including Puerto Rico. There was also…Official notice →
  9. US
    Drugs & medicalClass II

    Sensus Healthcare, Inc. recalls Sensus Healthcare Inc, SRT-100 Vision IPX 0, HFUS Module IPX 1, with software version 1.9.2; Superficial X-ray Radiation Therapy System…

    When the user pauses the beam delivery, the dose timer is reset (to zero), and as a result may deliver an unexpected dose to the patient.

    FDA · DeviceSensus Healthcare, Inc.US Distribution to states of: RX, IN, NM, FL, NY, FA, NC, IA, and IL.Official notice →
See all drugs & medical recalls →