Class I - Dangerous
CGMP Deviations
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Drugs Recalls
Prescription and over-the-counter medications
17,302 Total Recalls
Rocuronium Bromide 50 mg per 5mL (10mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC: 71449-004-11
Denver Solutions, LLC
Class I - Dangerous
Lack of Assurance of Sterility: Leaking/damaged syringes.
Class I - Dangerous
cGMP deviations
Class I - Dangerous
cGMP deviations
Duloxetine Delayed-Release Capsules USP, 60 mg, 1000-count bottles, Rx Only, Manufactured by Towa Pharmaceutical Europe, S.L., Distributed by Breckenridge Pharmaceutical, Inc. Berkeley Heights, NJ 07922, NDC# 51991-748-10
Breckenridge Pharmaceutical
Class I - Dangerous
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Class I - Dangerous
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Class I - Dangerous
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Class I - Dangerous
CGMP Deviations
Class I - Dangerous
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Class I - Dangerous
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Class I - Dangerous
cGMP deviations
Class I - Dangerous
cGMP deviations
Class I - Dangerous
cGMP deviations
Class I - Dangerous
Superpotent Drug: Assay/potency result for hydromorphone HCl in the compounded stability lot was higher than specification..
Class I - Dangerous
Lack of Assurance of Sterility: Leaking/damaged syringes.
Class I - Dangerous
Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during 18-month long term stability study.
Glycopyrrolate, 1mg per 5mL, (0.2 mg/mL), Single Dose 5 mL syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC 71449-104-11
Denver Solutions, LLC
Class I - Dangerous
Lack of Assurance of Sterility: Leaking/damaged syringes.
Ketamine HCl 50mg per 5mL (10 mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112.NDC: 71449-068-11
Denver Solutions, LLC
Class I - Dangerous
Lack of Assurance of Sterility: Leaking/damaged syringes.
Class I - Dangerous
CGMP Deviations
PHENYLephrine HCl in 0.9% Sodium Chloride, 0.5 mg per 5mL (100 mcg/mL), 5 mL Single Dose Syringe, Rx Only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC: 71449-001-11,
Denver Solutions, LLC
Class I - Dangerous
Lack of Assurance of Sterility: Leaking/damaged syringes.