Bi-Mix Injection (Alprostadil 80 mcg/Lidocaine 2 mg/mL) Pharm D Solutions, Houston, Texas --- NDC 69699-1317-03
Pharm D Solutions
Class I - Dangerous
Lack of Assurance of Sterility
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Prescription Drugs
💊 Drugs • 11,927 recalls
Class I - Dangerous
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
0.9% Sodium Chloride for Injection, 50 mL bags, Pharm D Solutions, Houston, Texas --- NDC 69699-1426-10
Pharm D Solutions
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class I - Dangerous
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Arginine Injections 100 mcg/mL, Pharm D Solutions, Houston, Texas NDC 69699-1414-20
Pharm D Solutions
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Bi-Mix Injection (Alprostadil 150 mcg/Lidocaine 2 mg/mL), Pharm D Solutions, Houston, Texas --- NDC 69699-1323-05
Pharm D Solutions
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
Defective Container: Repetitive complaints received indicating pump not working.
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.
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
Failed dissolution specifications: Out-of-Specification dissolution test result obtained during routine stability testing.
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.
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.