The Recall Desk

FDA (Drugs) recall action 91786

Breckenridge Pharmaceutical, Inc recalled 6 products on 2023-03-22

The FDA (Drugs) publishes a recall like this one as 6 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 6 pages.

Products
6
Announced
2023-03-22
Critical
0
Units
—

Why these products were recalled

CGMP Deviations: Potential risk of Cross Contamination

The agency’s own wording, quoted from the enforcement report.

1–6 of 6

  • HighFDA (Drugs)··2023-03-22

    Alprazolam Tablets Recalled for Potential Cross-Contamination from Manufacturing Deviations

    Breckenridge Pharmaceuticals is recalling Alprazolam 2 mg tablets nationwide due to manufacturing practice deviations creating potential cross-contamination risk. Affected tablets are distributed in 100-count and 500-count bottles.

    Product
    Alprazolam Tablets, USP, 2 mg, CIV, packaged in: a)100-count bottle (NDC 51991-0707-01) and b) 500-count bottle (NDC 51991-0707-05), Rx only, Manufactured by Centaur Pharmaceuticals PVT. LTD., Hinjewadi, Pune, INDIA, Distributed by: Breckenridge Pharmaceuticals, Inc., Berlin, CT
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2023-03-22

    Clobazam tablets recalled for potential manufacturing cross-contamination risk

    Breckenridge Pharmaceuticals is recalling certain lots of Clobazam 10 mg tablets due to a potential cross-contamination risk stemming from manufacturing process deviations.

    Product
    Clobazam Tablets, 10 mg, CIV, 100-count bottle, Rx only, Manufactured by Centaur Pharmaceuticals Pvt. Ltd., Pune, INDIA, Distributed by: Breckenridge Pharmaceuticals, Inc., Berlin, CT 06037, NDC 51991-900-01
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2023-03-22

    Alprazolam Tablets Recalled Due to Potential Cross-Contamination Risk

    Breckenridge Pharmaceutical is recalling multiple lots of Alprazolam 0.5mg tablets nationwide due to manufacturing process deviations that created a potential cross-contamination risk.

    Product
    Alprazolam Tablets, USP, 0.5mg, CIV, packaged in: a) 100-count bottle (NDC 51991-0705-01), b) 500-count bottle (NDC 51991-0705-05) and c) 1,000-count bottle (NDC 51991-0705-10), Rx only, Manufactured by Centaur Pharmaceuticals PVT. LTD., Hinjewadi, Pune, INDIA, Distributed by: B
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2023-03-22

    Alprazolam Tablets Recalled for Potential Cross-Contamination Risk

    Breckenridge Pharmaceuticals is recalling Alprazolam Tablets, USP 0.25mg distributed nationwide due to a potential cross-contamination risk from manufacturing deviations.

    Product
    Alprazolam Tablets, USP, 0.25mg, CIV, packaged in: a) 100-count bottle (NDC 51991-0704-01), b) 500-count bottle and c) 1,000-count bottle, Rx only, Manufactured by Centaur Pharmaceuticals PVT. LTD., Hinjewadi, Pune, INDIA, Distributed by: Breckenridge Pharmaceuticals, Inc., Berli
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2023-03-22

    Alprazolam Tablets Recalled for Potential Cross-Contamination from Manufacturing Deviations

    Breckenridge Pharmaceutical is recalling Alprazolam 1 mg tablets distributed nationwide due to manufacturing practice deviations that pose a potential cross-contamination risk.

    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) 1,000-count bottle (NDC 51991-0706-10), Rx only, Manufactured by Centaur Pharmaceuticals PVT. LTD., Hinjewadi, Pune, INDIA, Distributed by: Bre
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2023-03-22

    Clobazam Tablets Recalled Due to Cross Contamination Risk

    Breckenridge Pharmaceutical is recalling Clobazam 20 mg tablets (Lot #5210147, exp. 12/2023) nationwide due to potential cross contamination from manufacturing deviations.

    Product
    Clobazam Tablets, 20 mg, CIV, 100-count bottle, Rx only, Manufactured by Centaur Pharmaceuticals Pvt. Ltd., Pune, INDIA, Distributed by: Breckenridge Pharmaceuticals, Inc., Berlin, CT 06037, NDC 51991-901-01
    Category
    Distribution
    0 states