Breckenridge Pharmaceutical, Inc recalls
6 recalls on record · FDA
Every recall we have on record for Breckenridge Pharmaceutical, Inc, compiled from federal safety data. Check the hazard, the remedy, and how serious each one is, and always confirm on the official notice.
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Health Serious
Duloxetine Delayed-Release Capsules USP, 60 mg, 1000-count bottles, Rx Only, Manufactured…
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Breckenridge Pharmaceutical, Inc Apr 30, 2025
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Health Serious
Duloxetine Delayed-Release Capsules USP, 30 mg, a.) 90-count bottles (NDC# 51991-747-90),…
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Breckenridge Pharmaceutical, Inc Apr 30, 2025
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Health Serious
Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 90-count bottles (NDC…
CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Breckenridge Pharmaceutical, Inc Jan 1, 2025
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Health Serious
Alprazolam Tablets, USP, 1 mg, CIV, packaged in: a) 100-count bottle (NDC 51991-0706-01),…
CGMP Deviations: Potential risk of Cross Contamination
Breckenridge Pharmaceutical, Inc Mar 22, 2023
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Health Serious
Alprazolam Tablets, USP, 0.25mg, CIV, packaged in: a) 100-count bottle (NDC…
CGMP Deviations: Potential risk of Cross Contamination
Breckenridge Pharmaceutical, Inc Mar 22, 2023
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Health Serious
Alprazolam Tablets, USP, 0.5mg, CIV, packaged in: a) 100-count bottle (NDC…
CGMP Deviations: Potential risk of Cross Contamination
Breckenridge Pharmaceutical, Inc Mar 22, 2023
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