Class I - Dangerous
Microbial Contamination of Non-Sterile Products; Product was found to be contaminated with Sphingomonas paucimobilis bacteria.
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Prescription Drugs
💊 Drugs • 12,141 recalls
Class I - Dangerous
CGMP Deviations: tubing used for filling may interact with the nasal formulation of this product.
Class I - Dangerous
Lack of Assurance of Sterility; Product recalled due to displacement of the aluminum crimp cap during product usage.
Class I - Dangerous
Failed USP Dissolution Test Requirements: This sub-recall is in response to Prometheus Laboratories Inc. recall for Mercaptopurine USP 50mg because the lot does not meet the specification for dissolution.
Capex Shampoo (fluocinolone acetonide), Topical Shampoo, 0.01%, Rx only, For Topical Use Only, 4 fl oz in a 6 oz bottle, Marketed by: Galderma Laboratories, LP, Fort Worth, TX, Mfd. by: Hill Dermaceuticals, Inc., Sanford, FL --- NDC 0299-5500-04,
Galderma Laboratories, L.P.
Class I - Dangerous
Subpotent; fluocinolone acetonide.
Class I - Dangerous
Presence of Particulate Matter: A single visible particulate was observed and confirmed in a sample bottle during retain inspection.
Class I - Dangerous
Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration.
Class I - Dangerous
Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration.
Class I - Dangerous
Failed USP Dissolution Test Requirements: The recalled lots do not meet the specification for dissolution.
Class I - Dangerous
Defective container; lidding deformity allows the contained product to transpire causing potential viscosity and assay failures. The viscosity and assay failures were due to the loss of moisture. The loss of moisture caused the viscosity to increase and assay to increase relative to the sample volume
Class I - Dangerous
Marketed Without An Approved NDA/ANDA: Samples tested by FDA were found to contain sulfoaildenafil, an analogue of sildenafil, an FDA approved drug used in the treatment of male erectile dysfunction, making these products unapproved new drugs.
Class I - Dangerous
Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration.
Class I - Dangerous
Subpotent; fluocinolone acetonide
Class I - Dangerous
Failed PH specification: The lots of Carboplatin Injection were manufactured from Carboplatin API lots which trended out of specification low pH.
Class I - Dangerous
Labeling: Label Mix-Up: A typographical error in the product form on the carton label incorrectly lists the configuration as 30 "Capsules" (3 x 10) rather than "Tablets".
Class I - Dangerous
Subpotent; fluocinolone acetonide
HYDROCHLORIC ACID INJECTION 2MG/ML INJECTABLE 400 ML, 60 ML (2 DIFFERENT PRODUCTS)
Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Class I - Dangerous
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Superpotent (Single Ingredient) Drug: Some of the prefilled cartridge units have been found to be overfilled and contain more than the 1 mL labeled fill volume.
OXYGEN, COMPRESSED USP MEDICAL GAS in the following containers: E Cylinder 680L, D Cylinder 425L, and M6 Cylinder 165L, Rx only, Oklahoma Respiratory Care, Norman, OK
Oklahoma Respiratory Care
Class I - Dangerous
CGMP Deviations; no identity or purity testing on incoming oxygen gas, and lack of documentation
Class I - Dangerous
Lack of Assurance of Sterility