TURKEY .1 g/mL

Deva Holding AS - Cerkezkoy Subesi

CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.

USA LESS Inc.

Marketed Without An Approved NDA/ANDA: product tainted with undeclared sildenafil, an FDA approved drug for the treatment of male erectile dysfunction. The presence of sildenafil in Leopard Miracle Honey renders it an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.

Deva Holding AS - Cerkezkoy Subesi

CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.

Piramal Critical Care, Inc.

Labeling: Label Lacks Warning or Rx Legend: Finished product did not include the statement on the flip cap vial, "WARNING: PARALYZING AGENT"

Deva Holding AS - Cerkezkoy Subesi

CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.

Sagent Pharmaceuticals Inc

CGMP Deviations: product was not manufactured under current good manufacturing practices which contributed to Failed Impurities/Degradation Specifications as a high out of specification impurity result was detected during routine quality testing of stability samples.

Deva Holding AS - Cerkezkoy Subesi

CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.

Tsm Brands LLC

Labeling - product contains undeclared ethyl alcohol

Deva Holding AS - Cerkezkoy Subesi

CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.

Deva Holding AS - Cerkezkoy Subesi

CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.