💊 Drugs • 11,927 recalls
Mylan Pharmaceuticals
Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablet in bottle
Endo Pharmaceuticals
Lack of Assurance of Sterility: Defective container resulting in the lack of sterility assurance. ok thanks
Mckesson Packaging Services
Presence of Foreign Substance: foreign material found in the bulk inventory.
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
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.
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.
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
Labeling: Incorrect Instructions:outer carton contains the incorrect instructions for Step 2 stating "Do cut the patch" rather than the correct instructions of "Do not cut the patch". The pouch containing the patch is labeled correctly.