Class I - Dangerous
CGMP Deviations; particulates identified during visual inspection
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Drugs Recalls
Prescription and over-the-counter medications
17,302 Total Recalls
Class I - Dangerous
Failed Dissolution Specifications.
Class I - Dangerous
Sub-Potent Drug: Subpotent assay results during stability testing.
EVENITY, (romosozumab -aqqg) injection, 105mg/1.17 mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-880-02.
Mckesson Medical-Surgical Inc. Corporate Office
Class I - Dangerous
CGMP Deviations; potential temperature excursions due to transit delays
Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.
Class I - Dangerous
Sub-Potent Drug: Subpotent assay results during stability testing.
clomiPRAMINE Hydrochloride Capsules USP 25 mg, 100 count bottles, 5801 Pelican Bay Boulevard, Suite 500, Naples, Florida 34108, NDC# 68180-492-01
Lupin Pharmaceuticals
Class I - Dangerous
Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during retention sample testing at expiry.
BENLYSTA (belimumab) for injection, 400 mg/20 mL vial, Rx only, NDC 49401-102-01, GSK.
Mckesson Medical-Surgical Inc. Corporate Office
Class I - Dangerous
CGMP Deviations; potential temperature excursions due to transit delays
PROLIA (denosumab), injection, 60mg/mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-710-21
Mckesson Medical-Surgical Inc. Corporate Office
Class I - Dangerous
CGMP Deviations; potential temperature excursions due to transit delays
Class I - Dangerous
Product Mix Up: This product is being recalled because of a complaint received that a sealed bottle of lisinopril and hydrochlorothiazide tablets 20mg/12.5 mg had a foreign tablet identified as atazanavir and ritonavir tablet 300mg/100mg.
Class I - Dangerous
Subpotent Drug: Assay below the approved specification
PERIPHERAL PARENTERAL NUTRITION, Compounded Sterile Preparation, Refrigerated Injection, Rx Only, Single Dose Injection, a) 1440 mL bag, b) 1700 mL bag, Central Admixture Pharmacy Services, Inc, Los Angeles, 13128 Imperial Hwy, Santa Fe Spr., CA 90870.
Central Admixture Pharmacy Services, Inc (CAPS) Los Angeles
Class I - Dangerous
Lack of Processing Controls; prescriptions were compounded in an ISO-5 area where it was identified that a daily cleaning step was not sufficiently documented.
Class I - Dangerous
CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.
Class I - Dangerous
Subpotent Drug: Assay below the approved specification
Class I - Dangerous
Labeling: Incorrect or Missing Lot and/or Exp. Date: A printing issue resulted in incorrect lot numbers on the label.
Class I - Dangerous
Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.
Class I - Dangerous
CGMP Deviations
Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottles, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceuticals, Inc., Cranbury, NJ 08512, NDC 57664-051-88
SUN PHARMACEUTICAL INDUSTRIES
Class I - Dangerous
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 9 month long term stability station (25¿C, 60%RH).
Class I - Dangerous
Subpotent Drug: Assay below the approved specification
Class I - Dangerous
Subpotent Drug: Assay below the approved specification