11 FDA recalls mention Naloxone. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Naloxone.
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Reason Presence of Foreign Substance
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Reason Subpotent drug: Out of specification for assay of naloxone and buprenorphine (low)
Reason Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific…
Reason Presence of Particulate Matter; Potential for particulate matter on the syringe plunger.
Reason Failed Impurities/Degradation Specifications: out of specification test results for related compounds largest unknown impurity.
Reason Failed Impurities/Degradation Specifications: out of specification test results for related compounds largest unknown impurity.
Reason Failed Impurities/Degradation Specifications
Reason Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the…
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