CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Drugs Recalls
Prescription and over-the-counter medications
Piperacillin and Tazobactam for Injection, USP, 4.5 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-218-41
Astral SteriTech Private
Lack of Assurance of Sterility
CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Ceftriaxone for Injection, USP, 1 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-096-02
Astral SteriTech Private
Lack of Assurance of Sterility
Ceftriaxone for Injection, USP 2 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-214-42
Astral SteriTech Private
Lack of Assurance of Sterility
Ampicillin and Sulbactam for Injection, USP 15 grams per Pharmacy Bulk Package, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-083-01
Astral SteriTech Private
Lack of Assurance of Sterility
Ceftriaxone for Injection, USP 250 mg per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-094-02
Astral SteriTech Private
Lack of Assurance of Sterility
Cefepime for Injection, USP 1 gram per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC 72572-057-10
Astral SteriTech Private
Lack of Assurance of Sterility
Ceftriaxone for Injection, USP, 2 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-097-02
Astral SteriTech Private
Lack of Assurance of Sterility
CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Ampicillin for Injection, USP 500 mg per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-221-41
Astral SteriTech Private
Lack of Assurance of Sterility
Ceftriaxone for Injection, USP 10 grams per Pharmacy Bulk Package, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-215-15
Astral SteriTech Private
Lack of Assurance of Sterility
Lorazepam Injection, USP, 2mg/mL, 1 mL vial (NDC 0641-6044-01), packaged in 25 x 1 mL Vials per carton (NDC 0641-6044-25), Rx only, Manufactured by West-Ward, Eatontown, NJ 07724.
Hikma Pharmaceuticals USA
Failed Impurities/Degradation Specifications: Out-of-specification results for total related compounds observed during retain steting due to the elevated Related Compound-C.
Lack of Assurance of Sterility
Ampicillin and Sulbactam for Injection, USP 3 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-082-02
Astral SteriTech Private
Lack of Assurance of Sterility
Cefepime for Injection, USP 2 grams per vial, Rx only, Mfg. for: Piramal Critical Care Bethlehem, PA 18017 USA, NDC 66794-210-41
Astral SteriTech Private
Lack of Assurance of Sterility
Piperacillin and Tazobactam for Injection, USP 3.375 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-003-31
Astral SteriTech Private
Lack of Assurance of Sterility
Piperacillin and Tazobactam for Injection, USP, 2.25 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-002-31
Astral SteriTech Private
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility