Prescription and over-the-counter medications
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablets commingled
Incorrect/Undeclared excipients: inadvertent omission of a drug excipient from the the Authorized Generic label and also a warning regarding contact dermatitis from the brand product labeling not being incorporated into the Authorized Generic labeling.
Failed dissolution specifications - low dissolution results at S3 stage.
Jeffreys Drug Store
Marketed without an approved NDA/ANDA for which safety and efficacy has not been established.
Failed dissolution specifications - low dissolution results at S3 stage.
Amerisource Health Services
Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and Total Impurities
Lack of assurance of sterility
Failed Impurities/Degradation Specifications: The API for these products had an out of specification result for an organic impurity.
Failed Stability Specifications: confirmed out of specification results obtained during refrigerated material stability testing indicating that drug may settle within drug cassettes nearing the end of their refrigerated shelf-life
Failed Impurities/Degradation Specifications: The API for these products had an out of specification result for an organic impurity.
Pacific Medical Solutions
Marketed without an Approved NDA/ANDA and non-sterility: NANO PNC Water by nebulizer was sampled and found to contain variovorax paradoxus.
Lack of assurance of sterility
Failed Impurities/Degradation Specifications: Out of specification (OOS) for total impurity and out of trend for known impurity results encountered during stability testing.
Presence of Foreign Substance: consumer complaint for foreign matter embedded in the tablet identified as a broken piece of wire rope from the manufacturing equipment.
cGMP deviations - presence of rubber particles found loose in the bulk product.
Failed dissolution specifications - low dissolution results at S3 stage.
Lack of assurance of sterility
Non-Sterility: Direct evidence of contamination for 2 lots based on FDA samples.
Failed dissolution specifications - low dissolution results at S3 stage.
Mylan Pharmaceuticals
Presence of Foreign Tablets/Capsules; bottles of Glipizide 5 mg tablets may contain Glipizide 10 mg tablets