Reason Labeling: Incorrect or Missing Lot and/or Exp Date:The product labels contain a Two-Dimensional ( 2D ) barcode that, when scanned, reveals information specific to the batch of the labeled product, including Expiration Date. The expiration date included within these 2D barcodes is incorrect and does not match the correct expiration date listed on the face of the label itself.
Avella of Deer Valley, Inc. Store 38NDC 42852-822-71D-0997-2019
Reason Failed Impurities/Degradation Specifications: Out of specification test results in related substance at three-month long term stability study was obtained.
Reason Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Valeant Pharmaceuticals North America LLCNDC 68682-521-01D-0491-2019
Reason Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Valeant Pharmaceuticals North America LLCNDC 0187-0798-30D-0490-2019
Reason Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Valeant Pharmaceuticals North America LLCNDC 0187-0797-30D-0489-2019
Reason Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Valeant Pharmaceuticals North America LLCNDC 0187-0796-30D-0488-2019
Reason Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Valeant Pharmaceuticals North America LLCNDC 0187-0795-30D-0487-2019