💊 Drugs • 12,141 recalls
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.
Failed Dissolution Specifications
MOORE'S COMPOUNDING PHARMACY
Superpotent Drug and Subpotent Drug; potency failures obtained
Hospira Inc., A Pfizer Company
Lack of Sterility Assurance: customer report of leaking bag
Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and Total Impurities.
Labeling: Incorrect or Missing Lot and/or Exp Date: The expiration date of the Q Care Continue Care kit is printed with an expiration date of November 13, 2017; rather than the correct date of August 28, 2017 (date of expiration of the Corinz Antiseptic Cleansing & Moisturizing Oral Rinse). Note, the correct expiration date of August 28, 2017, is printed on the Corinz Oral Rinse package.
Failed Impurities/Degradation Specifications: out of specification test results for the norethindrone impurity.