Prescription Drugs

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

Presence of Foreign Tablet/ Capsule: Product complaint received indicating mix-up of one lisinopril 5mg tablet inside of a 30 mg, 100-count bottle of Lisinopril Tablets.

Failed Impurities/Degradation Specification: Presence of unknown impurity observed.

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

Failed impurities/degradation specification: Out-of-Specification result for total impurity at 4.1% (Limit: NMT 3.0%) during retained sample testing.

Defective Container: Recall is due to breaking and shattering of ampules upon opening

CGMP Deviations: poor manufacturing practices resulted in Labeling: Incorrect or Missing Lot and/or Exp Date, product incorrectly labeled with incorrect lot and expiration date.

Failed Stability Specifications

Presence of foreign tablet/capsule - Potential presence of commingled one Tacrolimus 1 mg capsule in 5 mg bottles.

Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.

Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.

SubPotent Drug: Low out-of-specification results for assay testing.

Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.

CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.

Labeling: Incorrect or Missing Exp Date - An incorrect expiration date has been identified on Prednisone Tablets USP 5 mg

CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.

Presence of particulate matter. presence of metal particles.