Class I - Dangerous
Subpotent
💊
Prescription Drugs
💊 Drugs • 12,141 recalls
Class I - Dangerous
Failed Content Uniformity Specifications; out-of-specification (OOS) results 18-month stability
Estriol Micronized, USP, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd, Qinhuangdao 066004, China 44132-007-06
Qinhuangdao Zizhu Pharmaceutical
Class I - Dangerous
cGMP Deviations; lack of quality assurance.
Class I - Dangerous
Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.
Class I - Dangerous
Presence of Foreign Tablet/Capsule; Amoxicillin 500 mg was found in bottles of Penicillin V potassium 500 mg
Class I - Dangerous
Lack of assurance of sterility: product was found to be empty, under-filled, or leaking.
hydrALAZINE HYDROCHLORIDE INJECTION, USP, 20 mg/mL, 1 mL Single Dose Vial, packaged in 25 Vials per carton, Rx only, APP Fresenius Kabi USA, LLC, Lake Surich, IL 60047, NDC 63323-614-01, Distributed by McKesson Medical-Surgical, Inc.
Mckesson Medical Surgical
Class I - Dangerous
Temperature Abuse: Certain pieces of these lots distributed by McKesson Medical Surgical Inc. were inadvertently stored refrigerated rather than the labeled room temperature recommendation.
Testosterone Micronized, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd., Qinhuangdao 066004, China (NDC 44132-006-06)
Qinhuangdao Zizhu Pharmaceutical
Class I - Dangerous
cGMP Deviations; lack of quality assurance.
Estradiol Micronized Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd, Qinhuangdao 066004, China (NDC 44132-001-01) (44132-001-06)
Qinhuangdao Zizhu Pharmaceutical
Class I - Dangerous
cGMP Deviations; lack of quality assurance.
Class I - Dangerous
Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.
Estrone Micronized, USP, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd., Qinhuangdao 066004, China (NDC 44132-003-04) (NDC 44132-003-02)(NDC 44132-003-06)
Qinhuangdao Zizhu Pharmaceutical
Class I - Dangerous
cGMP Deviations; lack of quality assurance.
Estradiol Non-Micronized, USP, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd, Qinhuangdao 066004, China
Qinhuangdao Zizhu Pharmaceutical
Class I - Dangerous
cGMP Deviations; lack of quality assurance.
Ethinyl Estradiol Micronized, USP, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd, Qinhuangdao 066004, China (NDC 44132-002-05)
Qinhuangdao Zizhu Pharmaceutical
Class I - Dangerous
cGMP Deviations; lack of quality assurance.
Levonorgestrel Non-Micronized, USP, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd., Qinhuangdao 066004, China (NDC 44132-012-01),
Qinhuangdao Zizhu Pharmaceutical
Class I - Dangerous
cGMP Deviations; lack of quality assurance.
Class I - Dangerous
Failed Tablet/Capsule Specifications; during an internal inspection, capsules were found with illegible print.
Class I - Dangerous
Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.
Class I - Dangerous
Chemical Contamination
Lumigan (bimatoprost ophthalmic solution) 0.01%, 7.5 mL bottle, Rx only, Allergan Irvine, CA 92612, NDC 0023-3205-08.
Allergan Sales
Class I - Dangerous
Failed Impurities/Degradation Specifications
Vancomycin HCl 750 mg added to 250 mL 0.9% Sodium Chloride For IV Use Only, Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0929-40
SCA Pharmaceuticals
Class I - Dangerous
Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter.
Vancomycin HCl 1.25 g added to 0.9% Sodium Chloride 250 mL Bag For IV Use Only, Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0923-59
SCA Pharmaceuticals
Class I - Dangerous
Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter.