Lidocaine Ophthalmic Gel 3.5%, 15mL bottles, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659,1(877) BELLA.
Bella Pharmaceuticals
Lack of Assurance of Sterility.
💊 Drugs • 12,141 recalls
Bella Pharmaceuticals
Lack of Assurance of Sterility.
Labeling: Not Elsewhere Classified; product is incorrectly labeled as Class III controlled substance instead of Class II controlled substance
Bella Pharmaceuticals
Lack of Assurance of Sterility.
Bella Pharmaceuticals
Lack of Assurance of Sterility.
Bella Pharmaceuticals
Lack of Assurance of Sterility.
Marketed without an approved NDA/ANDA: product label states it contains anabolic steroids.
Bella Pharmaceuticals
Lack of Assurance of Sterility.
Bella Pharmaceuticals
Lack of Assurance of Sterility.
Bella Pharmaceuticals
Lack of Assurance of Sterility.
Bella Pharmaceuticals
Lack of Assurance of Sterility.
Zydus Pharmaceuticals USA
Presence of Foreign tablets/capsules: risperidone Tablets were found in bottle of paroxetine Tablets
CGMP Deviations
ImprimisRx CA, Inc.
Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier
ImprimisRx CA, Inc.
Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier
ImprimisRx CA, Inc.
Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier
ImprimisRx CA, Inc.
Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier
Mckesson Packaging Services
Failed moisture limits: Out of specification for moisture content.
Defective container: Oral solution leaking from container.
Presence of Foreign Substance: customer complaint of blue foreign material identified as a portion of a nitrile glove was discovered in product.
Amphastar Pharmaceuticals
Crystallization: Particulate matter (Ketorolac Calcium Salt) was observed from several lots of retained samples.