Trimix ST-1 30PA-1.5PH-50A Aqueous Solution Pharm D Solutions, Houston, Texas --- NDC 69699-1388-05
Pharm D Solutions
Class I - Dangerous
Lack of Assurance of Sterility
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Drugs Recalls
Prescription and over-the-counter medications
17,685 Total Recalls
Class I - Dangerous
Defective Container: Repetitive complaints received indicating pump not working.
Class I - Dangerous
Failed Impurities/Degradation Specifications:Out of specification result noticed for total impurities observed during stability analysis
Cortaid Intensive Therapy Cooling Spray (1% hydrocortisone), 2 FL OZ (59 mL) spray bottle, OTC, Distributed by: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807, UPC code 301875518028
Valeant Pharmaceuticals North America
Class I - Dangerous
CGMP deviations: Notice received from supplier of a voluntary recall of all their nasal products and baby oral gels due to the possibility of microbial contamination. No positive results for the firm's products. were obtained. After the firm review, cGMP deviations ere evident.
Class I - Dangerous
Lack of assurance of sterility: loss of container integrity.
Cidofovir injection 375 mg/mL (75 mg/mL) vial Injection, 5 mL vials, Rx Only, Mfg. By Emcure Pharmaceutical Ltd Hinjawadi, Pune, India, Mfg for: Heritage Pharmaceuticals Inc. UPC 323155216388, NDC 23155-216-31
Heritage Pharmaceuticals
Class I - Dangerous
Lack of Assurance of Sterility: complaints received about dried powder on the outside of the bottle
Class I - Dangerous
Subpotent drug: During testing of the retention sample, the firm discovered that the product was sub-potent.
Cyclosporine 1% Human Eye Drops, Westlab Pharmacy, Inc., Gainesville, FL 32607 NDC 10002-2776-92
Westlab Pharmacy, Inc.
Class I - Dangerous
Lack of Process Controls
Class I - Dangerous
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Cortaid Maximum Strength Cream (1% hydrocortisone), 1 OZ (28 g) tube, OTC, Distributed by: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807, UPC code 301875521011
Valeant Pharmaceuticals North America
Class I - Dangerous
CGMP deviations: Notice received from supplier of a voluntary recall of all their nasal products and baby oral gels due to the possibility of microbial contamination. No positive results for the firm's products. were obtained. After the firm review, cGMP deviations ere evident.
Class I - Dangerous
Failed dissolution specifications: Out-of-Specification dissolution test result obtained during routine stability testing.
Class I - Dangerous
Lack of Process Controls
Class I - Dangerous
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Class I - Dangerous
CGMP Deviations: Detection of trace amounts of NDMA, a possible impurity or contaminant in an active pharmaceutical ingredient.
Class I - Dangerous
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Class I - Dangerous
CGMP Deviations: cleaning procedures during manufacturing caused out of specification results for unknown impurities.
Alprostadil 500 mcg/mL Injectable, Vials, Westlab Pharmacy, Inc., Gainesville, FL 32607 NDC 10002-7335-00
Westlab Pharmacy, Inc.
Class I - Dangerous
Incorrect Product Formulation
Class I - Dangerous
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Class I - Dangerous
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Bumetanide Tablets, USP, 2 mg, 100-count bottle, Rx only, Manufactured by: Upser-Smith Laboratories, LLC, Maple Grove, MN 55369, NDC 0832-0542-11
Upsher Smith Laboratories
Class I - Dangerous
Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product.